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The WaveLight® Analyzer is an ideal diagnostic device to support the decision-making process for personalized patient treatment paths. It measures the complete optics of the eye and calculates the individual wavefront aberrations. Therefore it enhances the range of possible treatments, from a Wavefront Optimized® procedure to sophisticated Wavefront-Guided treatments (Wavefront-Guided profiles are based on Wavefront Optimized® profiles for sphere and cylinder).

The WaveLight® Analyzer is a diagnostic device to support the decision-making process for personalized patient treatment paths. By calculating the individual wavefront aberrations of the eye, this device delivers measurement data for the preparation of Wavefront-Guided treatments.

The successful treatment of vision disorders requires accurate diagnosis. Developing a diagnostic device that is aligned with our laser systems was a logical step in order to help ensure a treatment that is right for the patient–from the beginning of diagnostics, through surgery and post-operative evaluation.

The rotating panel PC includes both a computer and monitor which can be used for showing patients their individual data.

Additionally, it is compact and provides an integrated USB port which is easily accessible and useful for data backup.

View Important Product Information for
All WaveLight® Excimer Laser Systems +

Important Product Information about the WaveLight® Excimer Laser Systems

This information pertains to all WaveLight® Excimer Laser Systems, including the WaveLight® ALLEGRETTO WAVE®, the ALLEGRETTO WAVE® Eye-Q , and the WaveLight® EX500.

Caution: Federal (U.S.) law restricts the WaveLight® Excimer Laser Systems to sale by or on the order of a physician. Only practitioners who are experienced in the medical mangement and surgical treatment of the cornea, who have been trained in laser refractive surgery (including laser calibration and operation) should use a WaveLight® Excimer Laser System.

Indications: FDA has approved the WaveLight® Excimer Laser for use in laser-assisted in situ keratomileusis (LASIK) treatments for:

  • the reduction or elimination of myopia of up to - 12.00 D and up to 6.00 D of astigmatism at the spectacle plane;
  • the reduction or elimination of hyperopia up to + 6.00 D with and without astigmatic refractive errors up to 5.00 D at the spectacle plane, with a maximum manifest refraction spherical equivalent of + 6.00 D;
  • the reduction or elimination of naturally occurring mixed astigmatism of up to 6.00 D at the spectacle plane; and
  • the wavefront-guided reduction or elimination of myopia of up to -7.00 D and up to 3.00 D of astigmatism at the spectacle plane.

In addition, FDA has approved the WaveLight® ALLEGRETTO WAVE® Eye-Q Excimer Laser System, when used with the WaveLight® ALLEGRO Topolyzer® and topography-guided treatment planning software for topography-guided LASIK treatments for the reduction or elimination of up to -9.00 D of myopia, or for the reduction or elimination of myopia with astigmatism, with up to -8.00 D of myopia and up to 3.00 D of astigmatism.

The WaveLight® Excimer Laser Systems are only indicated for use in patients who are 18 years of age or older (21 years of age or older for mixed astigmatism) with documentation of a stable manifest refraction defined as ≤ 0.50 D of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia.

Contraindications: The WaveLight® Excimer Laser Systems are contraindicated for use with patients who:

  • are pregnant or nursing;
  • have a diagnosed collagen vascular, autoimmune or immunodeficiency disease;
  • have been diagnosed keratoconus or if there are any clinical pictures suggestive of keratoconus;
  • are taking isotretinoin (Accutane*) and/or amiodarone hydrochloride (Cordarone*);
  • have severe dry eye;
  • have corneas too thin for LASIK;
  • have recurrent corneal erosion;
  • have advanced glaucoma; or
  • have uncontrolled diabetes.

Warnings: The WaveLight® Excimer Laser Systems are not recommended for use with patients who have:

  • systemic diseases likely to affect wound healing, such as connective tissue disease, insulin dependent diabetes, severe atopic disease or an immunocompromised status;
  • a history of Herpes simplex or Herpes zoster keratitis;
  • significant dry eye that is unresponsive to treatment;
  • severe allergies;
  • a history of glaucoma;
  • an unreliable preoperative wavefront examination that precludes wavefront-guided treatment; or
  • a poor quality preoperative topography map that precludes topography-guided LASIK treatment.

The wavefront-guided LASIK procedure requires accurate and reliable data from the wavefront examination. Every step of every wavefront measurement that may be used as the basis for a wavefront-guided LASIK procedure must be validated by the user. Inaccurate or unreliable data from the wavefront examination will lead to an inaccurate treatment.

Topography-guided LASIK requires preoperative topography maps of sufficient quality to use for planning a topography-guided LASIK treatment. Poor quality topography maps may affect the accuracy of the topography-guided LASIK treatment and may result in poor vision after topography-guided LASIK.

Precautions: The safety and effectiveness of the WaveLight® Excimer Laser Systems have not been established for patients with:

  • progressive myopia, hyperopia, astigmatism and/or mixed astigmatism, ocular disease, previous corneal or intraocular surgery, or trauma in the ablation zone;
  • corneal abnormalities including, but not limited to, scars, irregular astigmatism and corneal warpage;
  • residual corneal thickness after ablation of less than 250 microns due to the increased risk for corneal ectasia;
  • pupil size below 7.0 mm after mydriatics where applied for wavefront-guided ablation planning;
  • history of glaucoma or ocular hypertension of > 23 mmHg;
  • taking the medications sumatriptan succinate (Imitrex*);
  • corneal, lens and/or vitreous opacities including, but not limited to cataract;
  • iris problems including , but not limited to, coloboma and previous iris surgery compromising proper eye tracking; or
  • taking medications likely to affect wound healing including (but not limited to) antimetabolites.

In addition, safety and effectiveness of the WaveLight® Excimer Laser Systems have not been established for:

  • treatments with an optical zone < 6.0 mm or > 6.5 mm in diameter, or an ablation zone > 9.0 mm in diameter; or
  • wavefront-guided treatment targets different from emmetropia (plano) in which the wavefront calculated defocus (spherical term) has been adjusted;

In the WaveLight® Excimer Laser System clinical studies, there were few subjects with cylinder amounts > 4 D and ≤ 6 D. Not all complications, adverse events, and levels of effectiveness may have been determined for this population.

Pupil sizes should be evaluated under mesopic illumination conditions. Effects of treatment on vision under poor illumination cannot be predicted prior to surgery.

Adverse Events and Complications

Myopia: In the myopia clinical study, 0.2% (2/876) of the eyes had a lost, misplaced, or misaligned flap reported at the 1 month examination.

The following complications were reported 6 months after LASIK: 0.9% (7/818) had ghosting or double images in the operative eye; 0.1% (1/818) of the eyes had a corneal epithelial defect.

Hyperopia: In the hyperopia clinical study, 0.4% (1/276) of the eyes had a retinal detachment or retinal vascular accident reported at the 3 month examination.

The following complications were reported 6 months after LASIK: 0.8% (2/262) of the eyes had a corneal epithelial defect and 0.8% (2/262) had any epithelium in the interface.

Mixed Astigmatism: In the mixed astigmatism clinical study, two adverse events were reported. The first event involved a patient who postoperatively was subject to blunt trauma to the treatment eye 6 days after surgery. The patient was found to have an intact globe with no rupture, inflammation or any dislodgement of the flap. UCVA was decreased due to this event. The second event involved the treatment of an incorrect axis of astigmatism. The axis was treated at 60 degrees instead of 160 degrees.

The following complications were reported 6 months after LASIK: 1.8% (2/111) of the eyes had ghosting or double images in the operative eye.

Wavefront-Guided Myopia: The wavefront-guided myopia clinical study included 374 eyes treated; 188 with wavefront-guided LASIK (Study Cohort) and 186 with Wavefront Optimized® LASIK (Control Cohort). No adverse events occurred during the postoperative period of the wavefront-guided LASIK procedures. In the Control Cohort, one subject undergoing traditional LASIK had the axis of astigmatism programmed as 115 degrees instead of the actual 155 degree axis. This led to cylinder in the left eye.

The following complications were reported 6 months after wavefront-guided LASIK in the Study Cohort: 1.2% (2/166) of the eyes had a corneal epithelial defect; 1.2% (2/166) had foreign body sensation; and 0.6% (1/166) had pain. No complications were reported in the Control Cohort.

Topography-Guided Myopia: There were six adverse events reported in the topography-guided myopia study. Four of the eyes experienced transient or temporary decreases in vision prior to the final 12 month follow-up visit, all of which were resolved by the final follow-up visit. One subject suffered from decreased vision in the treated eye, following blunt force trauma 4 days after surgery. One subject experienced retinal detachment, which was concluded to be unrelated to the surgical procedure.

Clinical Data

Myopia: The myopia clinical study included 901 eyes treated, of which 813 of 866 eligible eyes were followed for 12 months. Accountability at 3 months was 93.8%, at 6 months was 91.9%, and at 12 months was 93.9%. Of the 782 eyes that were eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 6-month stability time point, 98.3% were corrected to 20/40 or better, and 87.7% were corrected to 20/20 or better. Subjects who responded to a patient satisfaction questionnaire before and after LASIK reported the following visual symptoms at a “moderate” or “severe” level at least 1% higher at 3 months post-treatment than at baseline: visual fluctuations (28.6% vs. 12.8% at baseline).

Long term risks of LASIK for myopia with and without astigmatism have not been studied beyond 12 months.

Hyperopia: The hyperopia clinical study included 290 eyes treated, of which 100 of 290 eligible eyes were followed for 12 months. Accountability at 3 months was 95.2%, at 6 months was 93.9%, and at 12 months was 69.9%. Of the 212 eyes that were eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 95.3% were corrected to 20/40 or better, and 69.4% were corrected to 20/20 or better. Subjects who responded to a patient satisfaction questionnaire before and after LASIK reported the following visual symptoms as “much worse” at 6 months post-treatment: halos (6.4%); visual fluctuations (6.1%); light sensitivity (4.9%); night driving glare (4.2%); and glare from bright lights (3.0%).

Long term risks of LASIK for hyperopia with and without astigmatism have not been studied beyond 12 months.

Mixed Astigmatism: The mixed astigmatism clinical study included 162 eyes treated, of which 111 were eligible to be followed for 6 months. Accountability at 1 month was 99.4%, at 3 months was 96.0%, and at 6 months was 100.0%. Of the 142 eyes that were eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 97.3% achieved acuity of 20/40 or better, and 69.4% achieved acuity of 20/20 or better. Subjects who responded to a patient satisfaction questionnaire before and after LASIK reported the following visual symptoms at a “moderate” or “severe” level at least 1% higher at 3 months post-treatment than at baseline: sensitivity to light (52.9% vs. 43.3% at baseline); visual fluctuations (43.0% vs. 32.1% at baseline); and halos (42.3% vs. 37.0% at baseline).

Long term risks of LASIK for mixed astigmatism have not been studied beyond 6 months.

Wavefront-Guided Myopia: The wavefront-guided myopia clinical study included 374 eyes treated; 188 with wavefront-guided LASIK (Study Cohort) and 186 with Wavefront Optimized® LASIK (Control Cohort). 166 of the Study Cohort and 166 of the Control Cohort were eligible to be followed at 6 months. In the Study Cohort, accountability at 1 month was 96.8%, at 3 months was 96.8%, and at 6 months was 93.3%. In the Control Cohort, accountability at 1 month was 94.6%, at 3 months was 94.6%, and at 6 months was 92.2%.

Of the 166 eyes in the Study Cohort that were eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 99.4% were corrected to 20/40 or better, and 93.4% were corrected to 20/20 or better. Of the 166 eyes in the Control Cohort eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 99.4% were corrected to 20/40 or better, and 92.8% were corrected to 20/20.

In the Study Cohort, subjects who responded to a patient satisfaction questionnaire before and after LASIK reported the following visual symptoms at a “moderate” or “severe” level at least 1% higher at 3 months post-treatment than at baseline: light sensitivity (47.8% vs. 37.2% at baseline) and visual fluctuations (20.0% vs. 13.8% at baseline). In the Control Cohort, the following visual symptoms were reported at a “moderate” or “severe” level at least 1% higher at 3 months post-treatment than at baseline: halos (45.4% vs. 36.6% at baseline) and visual fluctuations (21.9% vs. 18.3% at baseline).

Long term risks of wavefront-guided LASIK for myopia with and without astigmatism have not been studied beyond 6 months.

Topography-Guided Myopia: The topography-guided myopia clinical study included 249 eyes treated, of which 230 eyes were followed for 12 months. Accountability at 3 months was 99.2%, at 6 months was 98.0%, and at 12 months was 92.4%. Of the 247 eyes that were eligible for the UCVA analysis at the 3-month stability time point, 99.2% were corrected to 20/40 or better, and 92.7% were corrected to 20/20 or better. Subjects who responded to a patient satisfaction questionnaire before and after LASIK reported the following visual symptoms as “marked” or “severe” at an incidence greater than 5% at 1 month after surgery: dryness (7% vs. 4% at baseline) and light sensitivity (7% vs. 5% at baseline). Visual symptoms continued to improve with time, and none of the visual symptoms were rated as being “marked” or “severe” with an incidence of at least 5% at 3 months or later after surgery.

Long term risks of topography-guided LASIK for myopia with and without astigmatism have not been studied beyond 12 months.

Information for Patients: Prior to undergoing LASIK surgery with a WaveLight® Excimer Laser System, prospective patients must receive a copy of the relevant Patient Information Booklet, and must be informed of the alternatives for correcting their vision, including (but not limited to) eyeglasses, contact lenses, photorefractive keratectomy, and other refractive surgeries.

Attention: Please refer to a current WaveLight® Excimer Laser System Procedure Manual for a complete listing of the indications, complications, warnings, precautions, and side effects.

* Trademarks are property of their respective owners.

ALL13185WB

WaveLight® Diagonostics+

Important Product Information about the WaveLight® family of diagnostic devices (WaveLight® Topolyzer™ VARIO and WaveLight® Analyzer II).

Caution: Only practitioners trained in proper calibration and operation of these devices and who have experience in the use of the diagnostic information in the proper care and treatment of patients should use these devices.

Description and Intended Use: The WaveLight® Topolyzer™ VARIO and WaveLight® Analyzer II diagnostic devices are measuring instruments intended for use in eye examinations to measure corneal topography. Data from these systems may be exported and used to support refractive surgical procedures with the WaveLight® laser systems.

Important Warnings and Precautions: Refer to the User Manuals for the WaveLight® Topolyzer™ VARIO and WaveLight® Analyzer II diagnostic devices for a complete description of proper use and maintenance of these devices as well as a complete list of Warnings and Precautions. Refer to the Instruction For Use WaveLight® Excimer Laser Systems for a complete list of Indications, Warnings, Precautions and potential Adverse Effects associated with refractive surgical procedures.

These are sensitive measuring devices that require installation, calibration, operation and maintenance in accordance with the instructions and schedules provided in the User Manuals. If the systems have potentially been exposed to any type of shock that may have caused a misalignment of the instrument, it should be checked and, if necessary, appropriately serviced prior to use.

Users should take precautions when handling and using all accessories, disposable articles and agents that come into contact with the patient to prevent potential exposure to infectious agents.

Paper covers for the headrest should be properly discarded after each use and a new one used with each patient. The headrest should be cleaned after each patient use. Patients with open wounds and/or sores that may contact the headrest should not be treated.

Prior to measurement, the operator should verify the patient is not wearing contact lenses and only uninjured eyes are measured to ensure proper measurement.

The systems should only be installed and used in appropriate environments to ensure accurate measurement (e.g., use in a reflection-free surrounding outside of direct light).

These devices should not be used in the presence of combustible anesthetics or volatile solvents.

6/13 ALL13142BS

Important Product Information about the WaveLight® Excimer Laser Systems

This information pertains to all WaveLight® Excimer Laser Systems, including the WaveLight® ALLEGRETTO WAVE®, the ALLEGRETTO WAVE® Eye-Q , and the WaveLight® EX500.

Caution: Federal (U.S.) law restricts the WaveLight® Excimer Laser Systems to sale by or on the order of a physician. Only practitioners who are experienced in the medical mangement and surgical treatment of the cornea, who have been trained in laser refractive surgery (including laser calibration and operation) should use a WaveLight® Excimer Laser System.

Indications: FDA has approved the WaveLight® Excimer Laser for use in laser-assisted in situ keratomileusis (LASIK) treatments for:

  • the reduction or elimination of myopia of up to - 12.00 D and up to 6.00 D of astigmatism at the spectacle plane;
  • the reduction or elimination of hyperopia up to + 6.00 D with and without astigmatic refractive errors up to 5.00 D at the spectacle plane, with a maximum manifest refraction spherical equivalent of + 6.00 D;
  • the reduction or elimination of naturally occurring mixed astigmatism of up to 6.00 D at the spectacle plane; and
  • the wavefront-guided reduction or elimination of myopia of up to -7.00 D and up to 3.00 D of astigmatism at the spectacle plane.

In addition, FDA has approved the WaveLight® ALLEGRETTO WAVE® Eye-Q Excimer Laser System, when used with the WaveLight® ALLEGRO Topolyzer® and topography-guided treatment planning software for topography-guided LASIK treatments for the reduction or elimination of up to -9.00 D of myopia, or for the reduction or elimination of myopia with astigmatism, with up to -8.00 D of myopia and up to 3.00 D of astigmatism.

The WaveLight® Excimer Laser Systems are only indicated for use in patients who are 18 years of age or older (21 years of age or older for mixed astigmatism) with documentation of a stable manifest refraction defined as ≤ 0.50 D of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia.

Contraindications: The WaveLight® Excimer Laser Systems are contraindicated for use with patients who:

  • are pregnant or nursing;
  • have a diagnosed collagen vascular, autoimmune or immunodeficiency disease;
  • have been diagnosed keratoconus or if there are any clinical pictures suggestive of keratoconus;
  • are taking isotretinoin (Accutane*) and/or amiodarone hydrochloride (Cordarone*);
  • have severe dry eye;
  • have corneas too thin for LASIK;
  • have recurrent corneal erosion;
  • have advanced glaucoma; or
  • have uncontrolled diabetes.

Warnings: The WaveLight® Excimer Laser Systems are not recommended for use with patients who have:

  • systemic diseases likely to affect wound healing, such as connective tissue disease, insulin dependent diabetes, severe atopic disease or an immunocompromised status;
  • a history of Herpes simplex or Herpes zoster keratitis;
  • significant dry eye that is unresponsive to treatment;
  • severe allergies;
  • a history of glaucoma;
  • an unreliable preoperative wavefront examination that precludes wavefront-guided treatment; or
  • a poor quality preoperative topography map that precludes topography-guided LASIK treatment.

The wavefront-guided LASIK procedure requires accurate and reliable data from the wavefront examination. Every step of every wavefront measurement that may be used as the basis for a wavefront-guided LASIK procedure must be validated by the user. Inaccurate or unreliable data from the wavefront examination will lead to an inaccurate treatment.

Topography-guided LASIK requires preoperative topography maps of sufficient quality to use for planning a topography-guided LASIK treatment. Poor quality topography maps may affect the accuracy of the topography-guided LASIK treatment and may result in poor vision after topography-guided LASIK.

Precautions: The safety and effectiveness of the WaveLight® Excimer Laser Systems have not been established for patients with:

  • progressive myopia, hyperopia, astigmatism and/or mixed astigmatism, ocular disease, previous corneal or intraocular surgery, or trauma in the ablation zone;
  • corneal abnormalities including, but not limited to, scars, irregular astigmatism and corneal warpage;
  • residual corneal thickness after ablation of less than 250 microns due to the increased risk for corneal ectasia;
  • pupil size below 7.0 mm after mydriatics where applied for wavefront-guided ablation planning;
  • history of glaucoma or ocular hypertension of > 23 mmHg;
  • taking the medications sumatriptan succinate (Imitrex*);
  • corneal, lens and/or vitreous opacities including, but not limited to cataract;
  • iris problems including , but not limited to, coloboma and previous iris surgery compromising proper eye tracking; or
  • taking medications likely to affect wound healing including (but not limited to) antimetabolites.

In addition, safety and effectiveness of the WaveLight® Excimer Laser Systems have not been established for:

  • treatments with an optical zone < 6.0 mm or > 6.5 mm in diameter, or an ablation zone > 9.0 mm in diameter; or
  • wavefront-guided treatment targets different from emmetropia (plano) in which the wavefront calculated defocus (spherical term) has been adjusted;

In the WaveLight® Excimer Laser System clinical studies, there were few subjects with cylinder amounts > 4 D and ≤ 6 D. Not all complications, adverse events, and levels of effectiveness may have been determined for this population.

Pupil sizes should be evaluated under mesopic illumination conditions. Effects of treatment on vision under poor illumination cannot be predicted prior to surgery.

Adverse Events and Complications

Myopia: In the myopia clinical study, 0.2% (2/876) of the eyes had a lost, misplaced, or misaligned flap reported at the 1 month examination.

The following complications were reported 6 months after LASIK: 0.9% (7/818) had ghosting or double images in the operative eye; 0.1% (1/818) of the eyes had a corneal epithelial defect.

Hyperopia: In the hyperopia clinical study, 0.4% (1/276) of the eyes had a retinal detachment or retinal vascular accident reported at the 3 month examination.

The following complications were reported 6 months after LASIK: 0.8% (2/262) of the eyes had a corneal epithelial defect and 0.8% (2/262) had any epithelium in the interface.

Mixed Astigmatism: In the mixed astigmatism clinical study, two adverse events were reported. The first event involved a patient who postoperatively was subject to blunt trauma to the treatment eye 6 days after surgery. The patient was found to have an intact globe with no rupture, inflammation or any dislodgement of the flap. UCVA was decreased due to this event. The second event involved the treatment of an incorrect axis of astigmatism. The axis was treated at 60 degrees instead of 160 degrees.

The following complications were reported 6 months after LASIK: 1.8% (2/111) of the eyes had ghosting or double images in the operative eye.

Wavefront-Guided Myopia: The wavefront-guided myopia clinical study included 374 eyes treated; 188 with wavefront-guided LASIK (Study Cohort) and 186 with Wavefront Optimized® LASIK (Control Cohort). No adverse events occurred during the postoperative period of the wavefront-guided LASIK procedures. In the Control Cohort, one subject undergoing traditional LASIK had the axis of astigmatism programmed as 115 degrees instead of the actual 155 degree axis. This led to cylinder in the left eye.

The following complications were reported 6 months after wavefront-guided LASIK in the Study Cohort: 1.2% (2/166) of the eyes had a corneal epithelial defect; 1.2% (2/166) had foreign body sensation; and 0.6% (1/166) had pain. No complications were reported in the Control Cohort.

Topography-Guided Myopia: There were six adverse events reported in the topography-guided myopia study. Four of the eyes experienced transient or temporary decreases in vision prior to the final 12 month follow-up visit, all of which were resolved by the final follow-up visit. One subject suffered from decreased vision in the treated eye, following blunt force trauma 4 days after surgery. One subject experienced retinal detachment, which was concluded to be unrelated to the surgical procedure.

Clinical Data

Myopia: The myopia clinical study included 901 eyes treated, of which 813 of 866 eligible eyes were followed for 12 months. Accountability at 3 months was 93.8%, at 6 months was 91.9%, and at 12 months was 93.9%. Of the 782 eyes that were eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 6-month stability time point, 98.3% were corrected to 20/40 or better, and 87.7% were corrected to 20/20 or better. Subjects who responded to a patient satisfaction questionnaire before and after LASIK reported the following visual symptoms at a “moderate” or “severe” level at least 1% higher at 3 months post-treatment than at baseline: visual fluctuations (28.6% vs. 12.8% at baseline).

Long term risks of LASIK for myopia with and without astigmatism have not been studied beyond 12 months.

Hyperopia: The hyperopia clinical study included 290 eyes treated, of which 100 of 290 eligible eyes were followed for 12 months. Accountability at 3 months was 95.2%, at 6 months was 93.9%, and at 12 months was 69.9%. Of the 212 eyes that were eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 95.3% were corrected to 20/40 or better, and 69.4% were corrected to 20/20 or better. Subjects who responded to a patient satisfaction questionnaire before and after LASIK reported the following visual symptoms as “much worse” at 6 months post-treatment: halos (6.4%); visual fluctuations (6.1%); light sensitivity (4.9%); night driving glare (4.2%); and glare from bright lights (3.0%).

Long term risks of LASIK for hyperopia with and without astigmatism have not been studied beyond 12 months.

Mixed Astigmatism: The mixed astigmatism clinical study included 162 eyes treated, of which 111 were eligible to be followed for 6 months. Accountability at 1 month was 99.4%, at 3 months was 96.0%, and at 6 months was 100.0%. Of the 142 eyes that were eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 97.3% achieved acuity of 20/40 or better, and 69.4% achieved acuity of 20/20 or better. Subjects who responded to a patient satisfaction questionnaire before and after LASIK reported the following visual symptoms at a “moderate” or “severe” level at least 1% higher at 3 months post-treatment than at baseline: sensitivity to light (52.9% vs. 43.3% at baseline); visual fluctuations (43.0% vs. 32.1% at baseline); and halos (42.3% vs. 37.0% at baseline).

Long term risks of LASIK for mixed astigmatism have not been studied beyond 6 months.

Wavefront-Guided Myopia: The wavefront-guided myopia clinical study included 374 eyes treated; 188 with wavefront-guided LASIK (Study Cohort) and 186 with Wavefront Optimized® LASIK (Control Cohort). 166 of the Study Cohort and 166 of the Control Cohort were eligible to be followed at 6 months. In the Study Cohort, accountability at 1 month was 96.8%, at 3 months was 96.8%, and at 6 months was 93.3%. In the Control Cohort, accountability at 1 month was 94.6%, at 3 months was 94.6%, and at 6 months was 92.2%.

Of the 166 eyes in the Study Cohort that were eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 99.4% were corrected to 20/40 or better, and 93.4% were corrected to 20/20 or better. Of the 166 eyes in the Control Cohort eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 99.4% were corrected to 20/40 or better, and 92.8% were corrected to 20/20.

In the Study Cohort, subjects who responded to a patient satisfaction questionnaire before and after LASIK reported the following visual symptoms at a “moderate” or “severe” level at least 1% higher at 3 months post-treatment than at baseline: light sensitivity (47.8% vs. 37.2% at baseline) and visual fluctuations (20.0% vs. 13.8% at baseline). In the Control Cohort, the following visual symptoms were reported at a “moderate” or “severe” level at least 1% higher at 3 months post-treatment than at baseline: halos (45.4% vs. 36.6% at baseline) and visual fluctuations (21.9% vs. 18.3% at baseline).

Long term risks of wavefront-guided LASIK for myopia with and without astigmatism have not been studied beyond 6 months.

Topography-Guided Myopia: The topography-guided myopia clinical study included 249 eyes treated, of which 230 eyes were followed for 12 months. Accountability at 3 months was 99.2%, at 6 months was 98.0%, and at 12 months was 92.4%. Of the 247 eyes that were eligible for the UCVA analysis at the 3-month stability time point, 99.2% were corrected to 20/40 or better, and 92.7% were corrected to 20/20 or better. Subjects who responded to a patient satisfaction questionnaire before and after LASIK reported the following visual symptoms as “marked” or “severe” at an incidence greater than 5% at 1 month after surgery: dryness (7% vs. 4% at baseline) and light sensitivity (7% vs. 5% at baseline). Visual symptoms continued to improve with time, and none of the visual symptoms were rated as being “marked” or “severe” with an incidence of at least 5% at 3 months or later after surgery.

Long term risks of topography-guided LASIK for myopia with and without astigmatism have not been studied beyond 12 months.

Information for Patients: Prior to undergoing LASIK surgery with a WaveLight® Excimer Laser System, prospective patients must receive a copy of the relevant Patient Information Booklet, and must be informed of the alternatives for correcting their vision, including (but not limited to) eyeglasses, contact lenses, photorefractive keratectomy, and other refractive surgeries.

Attention: Please refer to a current WaveLight® Excimer Laser System Procedure Manual for a complete listing of the indications, complications, warnings, precautions, and side effects.

* Trademarks are property of their respective owners.

ALL13185WB

WaveLight® Allegretto Wave® EX500 System

Health Care Professional Information Sheet-All WaveLight® Allegretto Wave® EX500 System Indications

The WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Statements regarding the potential benefits of wavefront-guided and Wavefront Optimized® laser-assisted in-situ keratomileusis (LASIK) are based upon the results of clinical trials. These results are indicative of not only the WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System treatment but also the care of the clinical physicians, the control of the surgical environment by those physicians, the clinical trials’ treatment parameters and the clinical trials’ patient inclusion and exclusion criteria. Although many clinical trial patients after the wavefront-guided and Wavefront Optimized® procedure saw 20/20 or better and/or had or reported having better vision during the day and at night, compared to their vision with glasses or contact lenses before the procedure, individual results may vary. You can find information about the clinical trials below and in the Procedure Manuals for the WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System.

As with any surgical procedure, there are risks associated with the wavefront-guided and Wavefront Optimized® treatment. Before treating patients with these procedures, you should carefully review the Procedure Manuals, complete the Physician WaveLight® System Certification Course, provide your patients with the Patient Information Booklet, and discuss the risks associated with this procedure and questions about the procedure with your patients.

Indications: The WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System is indicated to perform LASIK treatments in patients with documented evidence of a stable manifest refraction defined as less than or equal to 0.50 diopters (D) of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia in patients 18 years of age or older: for the reduction or elimination of myopic refractive errors up to -12.0 D of sphere with and without astigmatic refractive errors up to -6.0 D; for the reduction or elimination of hyperopic refractive errors up to +6.0 D of sphere with and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D; in conjunction with the WaveLight® ALLEGRO Analyzer® device for the reduction or elimination of up to -7.0 D of spherical equivalent myopia or myopia with astigmatism, with up to -7.0 D of spherical component and up to 3.0 D of astigmatic component at the spectacle plane; and in patients 21 years of age or older for the reduction or elimination of naturally occurring mixed astigmatism of up to 6.0 D at the spectacle plane.

LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), and other refractive surgeries. Only practitioners who are experienced in the medical management and surgical treatment of the cornea, who have been trained in laser refractive surgery including laser system calibration and operation, may use the device as approved. Prospective patients, as soon as they express an interest in an indicated LASIK procedure and prior to undergoing surgery, must be given the WaveLight® System Patient Information Booklet and must be informed of the alternatives for refractive correction including eyeglasses, contact lenses, PRK, and other refractive surgeries.

Clinical Data Myopia: The WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System was studied in clinical trials in the United States with 901 eyes treated, of which 813 of 866 eligible eyes were followed for 12 months. Accountability at 3 months was 93.8%, at 6 months was 91.9%, and at 12 months was 93.9%.

The studies found that of the 844 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 3-month stability time point, 98.0% were corrected to 20/40 or better, and 84.4% were corrected to 20/20 or better without spectacles or contact lenses.

The clinical trials showed that the following subjective patient adverse events were reported as moderate to severe at a level at least 1% higher than baseline of the subjects at 3 months post-treatment: visual fluctuations (12.8% at baseline versus 28.6% at 3 months). Long term risks of LASIK for myopia with and without astigmatism beyond 12 months have not been studied.

Clinical Data Hyperopia: The WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System has been studied in clinical trials in the United States with 290 eyes treated, of which 100 of 290 eligible eyes were followed for 12 months. Accountability at 3 months was 95.2%, at 6 months was 93.9%, and at 12 months was 69.9%.

The studies found that of the 212 eyes eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 95.3% were corrected to 20/40 or better, and 67.5% were corrected to 20/20 or better without spectacles or contact lenses.

The study showed that the following subjective patient adverse events were reported as much worse by at least 1% of the subjects (in order of increasing frequency) at 6 months post final treatment: glare from bright lights (3.0%); night driving glare (4.2%); light sensitivity (4.9%); visual fluctuations (6.1%); and halos (6.4%). Long term risks of LASIK for hyperopia with and without astigmatism beyond 12 months have not been studied.

Clinical Data Mixed Astigmatism: The WaveLight® ALLEGRETTO WAVE®/ ALLEGRETTO WAVE® Eye-Q Excimer Laser System has been studied in clinical trials in the United States with 162 eyes treated, of which 111 were eligible to be followed at 6 months. Accountability at 1 month was 99.4%, at 3 months was 96.0%, and at 6 months was 100.0%.

The studies found that of the 142 eyes eligible for the UCVA analysis of effectiveness at the 3-month stability time point, 95.8% achieved acuity of 20/40 or better, and 67.6% achieved acuity of 20/20 or better without spectacles or contact lenses.

The clinical trials showed that the following subjective patient adverse events were reported as moderate to severe at a level at least 1% higher than baseline of the subjects at 3 months post-treatment: sensitivity to light (43.3% at baseline versus 52.9% at 3 months); visual fluctuations (32.1% at baseline versus 43.0% at 3 months); and halos (37.0% at baseline versus 42.3% at 3 months). Long term risks of LASIK for mixed astigmatism beyond 6 months have not been studied.

Clinical Data Wavefront-guided Treatment of Myopia: The WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System used in conjuction with the WaveLight ALLEGRETTO device was studied in a randomized clinical trial in the United States with 374 eyes treated; 188 with wavefront-guided LASIK (Study Cohort) and 186 with Wavefront Optimized® LASIK (Control Cohort). 178 of the Study Cohort and 180 of the Control Cohort were eligible to be followed at 6 months. In the Study Cohort, accountability at 1 month was 96.8%, at 3 months was 96.8%, and at 6 months was 93.3%. In the Control Cohort, accountability at 1 month was 94.6%, at 3 months was 94.6%, and at 6 months was 92.2%.

The studies found that of the 180 eyes eligible for the UCVA analysis of effectiveness at the 6-month stability time point in the Study Cohort, 99.4% were corrected to 20/40 or better, and 93.4% were corrected to 20/20 or better without spectacles or contact lenses. In the Control Cohort, of the 176 eyes eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 99.4% were corrected to 20/40 or better, and 92.8% were corrected to 20/20 or better without spectacles or contact lenses.

The clinical trials showed that the following subjective patient adverse events were reported as moderate to severe at a level at least 1% higher than baseline of the subjects at 3 months post-treatment in the Study Cohort: light sensitivity (37.2% at baseline versus 47.8% at 3 months); and visual fluctuations (13.8% at baseline versus 20.0% at 3 months). In the Control Cohort: halos (36.6% at baseline versus 45.4% at 3 months); and visual fluctuations (18.3% at baseline versus 21.9% at 3 months). Long term risks of wavefront-guided LASIK for myopia with and without astigmatism beyond 6 months have not been studied.

Contraindications: LASIK treatments using the WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System are contraindicated if any of the following conditions exist. Potential contraindications are not limited to those included in this list: pregnant or nursing women; patients with a diagnosed collagen vascular, autoimmune or immunodeficiency disease; patients with diagnosed keratoconus or any clinical pictures suggestive of keratoconus; and patients who are taking one or both of the following medications: isotretinoin (Accutane®1), amiodarone hydrochloride (Cordarone®2).

Warnings: Any LASIK treatment with the WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System is not recommended in patients who have: systemic diseases likely to affect wound healing, such as connective tissue disease, insulin dependent diabetes, severe atopic disease or an immunocompromised status; a history of Herpes simplex or Herpes zoster keratitis; significant dry eye that is unresponsive to treatment; severe allergies; and unreliable preoperative wavefront examination that precludes wavefront-guided treatment. The wavefront-guided LASIK procedure requires accurate and reliable data from the wavefront examination. Every step of every wavefront measurement that may be used as the basis for a wavefront-guided LASIK procedure must be validated by the user. Inaccurate or unreliable data from the wavefront examination will lead to an inaccurate treatment.

Precautions: Safety and effectiveness of the WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System have not been established for patients with: progressive myopia, hyperopia, astigmatism and/or mixed astigmatism; ocular disease; previous corneal or intraocular surgery, or trauma in the ablation zone; corneal abnormalities including, but not limited to, scars, irregular astigmatism and corneal warpage; residual corneal thickness after ablation of less than 250 microns increasing the risk for corneal ectasia; pupil size below 7.0 mm after mydriatics where applied for wavefront-guided ablation planning; history of glaucoma or ocular hypertension of > 23 mmHg; taking the medication sumatriptan succinate (Imitrex®3); under 18 years (21 years for mixed astigmatism) of age; over the long term (more than 12 months after surgery); corneal, lens and/or vitreous opacities including, but not limited to, cataract; iris problems including, but not limited to, coloboma and previous iris surgery compromising proper eyetracking; taking medications likely to affect wound healing including, but not limited to, antimetabolites; treatments with an optical zone below 6.0 mm or above 6.5 mm in diameter; treatment targets different from emmetropia (plano) in which the wavefront-calculated defocus (spherical term) has been adjusted; myopia greater than – 12.0 D or astigmatism greater than 6 D; hyperopia greater than + 6.0 D or astigmatism greater than 5.0 D; mixed astigmatism greater than + 6.0 D; and in cylinder amounts > 4.0 to < 6.0 D.

Due to the lack of large numbers of patients in the general population, there are few subjects with cylinder amounts in this range to be studied. Not all complications, adverse events, and levels of effectiveness may have been determined.

Pupil sizes should be evaluated under mesopic illumination conditions. Effects of treatment on vision under poor illumination cannot be predicted prior to surgery. Some patients may find it more difficult to see in such conditions as very dim light, rain, fog, snow and glare from bright lights. This has been shown to occur more frequently in the presence of residual refractive error and perhaps in patients with pupil sizes larger than the optical zone size.

The refraction is determined in the spectacle plane, but treated in the corneal plane. In order to determine the right treatment program to achieve the right correction, assessment of the vertex distance during refraction testing is recommended. Preoperative evaluation for dry eyes should be performed. Patients should be advised of the potential for dry eyes post LASIK and post wavefront-guided LASIK surgery. This treatment can only be provided by a licensed healthcare professional.

Adverse Events and Complications for Myopia: Certain adverse events and complications occurred after the LASIK surgery. Two adverse events occurred during the postoperative period of the clinical study: 0.2% (2/876) had a lost, misplaced, or misaligned flap reported at the 1 month examination.

The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment, corneal edema at 1 month or later visible in the slit lamp exam; any complication leading to intraocular surgery; melting of the flap of >1 mm2; epithelium of >1 mm2 in the interface with loss of 2 lines or more of BSCVA; uncontrolled IOP rise with increase of >5 mmHg or any reading above 25 mmHg; retinal detachment or retinal vascular accident; and decrease in BSCVA of >10 letters not due to irregular astigmatism as shown by hard contact lens refraction.

The following complications occurred 3 months after LASIK during this clinical trial: 0.8% (7/844) of eyes had a corneal epithelial defect; 0.1% (1/844) had any epithelium in the interface; 0.1% (1/844) had foreign body sensation; 0.2% (2/844) had pain; and 0.7% (6/844) had ghosting or double images in the operative eye.

The following complications did NOT occur 3 months following LASIK in this clinical trial: corneal edema and need for lifting and/or reseating the flap/cap.

Adverse Events and Complications for Hyperopia: Certain adverse events and complications occurred after the LASIK surgery. Only one adverse event occurred during the clinical study: one eye (0.4%) had a retinal detachment or retinal vascular accident reported at the 3 month examination.

The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment; lost, misplaced, or misaligned flap, or any flap/cap problems requiring surgical intervention beyond 1 month; corneal edema at 1 month or later visible in the slit lamp exam; any complication leading to intraocular surgery; melting of the flap of > 1 mm2; epithelium of > 1 mm2 in the interface with loss of 2 lines or more of BSCVA; uncontrolled IOP rise with increase of > 5 mmHg or any reading above 25 mmHg and decrease in BSCVA of > 10 letters not due to irregular astigmatism as shown by hard contact lens refraction.

The following complications occurred 6 months after LASIK during this clinical trial: 0.8% (2/262) of eyes had a corneal epithelial defect and 0.8% (2/262) had any epithelium in the interface.

The following complications did NOT occur 6 months following LASIK in this clinical trial: corneal edema; foreign body sensation; pain, ghosting or double images; and need for lifting and/or reseating of the flap/cap.

Adverse Events and Complications for Mixed Astigmatism: Certain adverse events and complications occurred after the LASIK surgery. No protocol defined adverse events occurred during the clinical study. However, two events occurred which were reported to the FDA as Adverse Events.

The first event involved a patient who postoperatively was subject to blunt trauma to the treatment eye 6 days after surgery. The patient was found to have an intact globe with no rupture, inflammation or any dislodgement of the flap. The second event involved the treatment of an incorrect axis of astigmatism which required retreatment.

The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment; corneal epithelial defect involving the keratectomy at 1 month or later; corneal edema at 1 month or later visible in the slit lamp exam; epithelium of > 1 mm2 in the interface with loss of 2 lines or more of BSCVA; lost, misplaced, or misaligned flap, or any flap/cap problems requiring surgical intervention beyond 1 month; decrease in BSCVA of > 10 letters not due to irregular astigmatism as shown by hard contact lens refraction; any complication leading to intraocular surgery; melting of the flap of > 1 mm2; uncontrolled IOP rise and retinal detachment or retinal vascular accident.

None of the following complications occurred at 3 months after LASIK during this clinical trial: corneal edema; corneal epithelial defect; any epithelium in the interface; foreign body sensation, pain, ghosting or double images; and need for lifting and/or reseating of the flap/cap.

Subjects were asked to complete a patient questionnaire preoperatively and at 3-months, 6-months, and 1-year postoperatively.

Adverse Events and Complications for Wavefront - guided Myopia: Certain adverse events and complications occurred after the wavefront-guided LASIK surgery. No adverse event occurred during wavefront-guided treatments during this clinical study.

The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment; lost, misplaced or misaligned flap or any flap/cap problems requiring surgical intervention beyond 1 month; corneal edema at 1 month or later visible in the slit lamp exam; any complication leading to intraocular surgery; melting of the flap of > 1 mm2; epithelium of > 1 mm2 in the interface with loss of 2 lines or more of BSCVA; uncontrolled IOP rise with increase of > 5 mmHg or any reading above 25 mmHg; and decrease in BSCVA of > 10 letters not due to irregular astigmatism as shown by hard contact lens refraction.

The following complications occurred 3 months after wavefront-guided LASIK during this clinical trial: corneal epithelial defect (0.6%); foreign body sensation (0.6%); and pain (0.6%).

The following complications did NOT occur 3 months following wavefront-guided LASIK in this clinical trial: corneal edema; any epithelium in the interface; ghosting or double images; and need for lifting and/or reseating of the flap/cap.

ATTENTION: The safety and effectiveness of LASIK surgery has ONLY been established with an optical zone of 6.0—6.5 mm and an ablation zone of 9.0 mm.

Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions.

  1. Accutane® is a registered trademark of Hoffmann-La Roche Inc.
  2. Cordarone® is a registered trademark of Sanofi S.A.
  3. Imitrex® is a registered trademark Glaxo Group Limited.

Important Product Information about the WaveLight® FS200 Laser System

CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

INDICATIONS: The WaveLight® FS200 Laser System is indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea; in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; in the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty; and in the creation of a penetrating cut/incision for penetrating keratoplasty and for corneal harvesting.

The WaveLight® FS200 delivery system is used in conjunction with a sterile disposable Patient Interface, consisting of pre-sterilized suction ring assemblies and pre-sterilized applanation cones, intended for single use.

The WaveLight® FS200 Laser System should only be operated by, or under the direct supervision of, a trained physician with certification in laser safety and in the use of the WaveLight® FS200 Laser.

CONTRAINDICATIONS: LASIK treatments are contraindicated in: Pregnant or nursing women; patients with a diagnosed collagen vascular, autoimmune or immunodeficiency disease; and patients who are taking one or both of the following medications: isotretinoin (Accutane*), amiodarone hydrochloride (Cordarone*).

Flap Contraindications: Lamellar resection for the creation of a corneal flap using the WaveLight® FS200 laser is contraindicated if any of the following conditions exist. Potential contraindications are not limited to those included in this list: corneal edema; corneal lesions; hypotony; glaucoma; existing corneal implant; and keratoconus.

Keratoplasty Contraindications: Penetrating cut/incision (for penetrating keratoplasty) is contraindicated in: any corneal opacity adequately dense to obscure visualization of the iris; descemetocoete with impending corneal rupture; previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape; and corneal thickness requirements that are beyond the range of the System.

Other Considerations: The following conditions should also be considered: severe corneal thinning; subjects with pre-existing glaucoma; a history of steroid responsive rise in intraocular pressure; preoperative intraocular pressure greater than 21 mmHg in the operative eye; subjects with more than 1000 μm corneal thickness at the 9 mm peripheral zone; active intraocular inflammation; and active ocular infection.

WARNINGS: Any treatment with the WaveLight® FS200 is not recommended in patients who have: systemic diseases likely to affect wound healing, such as connective tissue disease, insulin dependent diabetes, severe atopic disease or an immunocompromised status; a history of Herpes simplex or Herpes zoster keratitis; significant dry eye that is unresponsive to treatment; severe allergies; and a history of glaucoma or ocular hypertension.

COMPLICATIONS: Possible complications which may result from flap cutting include (potential complications are not limited to those included in this list): corneal edema; corneal pain; epithelial ingrowth; epithelial infection; flap de-centration; incomplete flap creation; flap tearing or incomplete lift-off; free cap; photophobia; corneal inflammation, such as diffuse lamellar keratitis (DLK), corneal infiltrates and iritis; thin- or thick flaps; flap striae; and corneal ectasia (secondary keratoconus).

ADVERSE EVENTS:

Transient Light Sensitivity Syndrome (TLSS): Transient Light Sensitivity Syndrome is characterized by symptoms of mild to severe light sensitivity which manifests between two and six weeks postoperatively. Patients experience no decrease in uncorrected or best spectacle-corrected visual acuity. The incidence of this sensitivity was observed in approximately 1% of patients who undergo flap creation with a femtosecond laser.* Patients respond to the use of hourly topical steroids such as prednisolone acetate, and most report improvement within one week of treatment.

Peripheral Light Spectrum (PLS): Peripheral Light Spectrum is a temporary phenomenon whereby patients report the perception of a spoke-like spectrum of light in the periphery of their vision. PLS has no clinical examination findings and no effect on visual acuity; however the potential diffractive effects may be bothersome to some patients. Reported in only a small amount of cases, the onset of symptoms occurs during the immediate postoperative period, and typically resolves within three months but may be slightly persistent in rare cases. The visual impact of PLS is clinically inconsequential for the vast majority of patients.

ATTENTION: Please refer to a current WaveLight® FS200 Laser System Procedure Manual for a complete listing of the indications, complications, warnings, precautions, and side effects.

*Trademarks are the property of their respective owners.

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