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VERION™ Reference Unit and VERION™ Digital Marker       +

VERION IMAGE GUIDED SYSTEM IMPORTANT PRODUCT INFORMATION

Verion Reference Unit and Verion Digital Marker

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

INTENDED USES: The Verion Reference Unit is a preoperative measurement device that captures and utilizes a high-resolution reference image of a patient's eye. In addition, the Verion Reference Unit provides pre-operative surgical planning functions to assist the surgeon with planning cataract surgical procedures. The Verion Reference Unit also supports the export of the reference image, preoperative measurement data, and surgical plans for use with the Verion Digital Marker and other compatible devices through the use of a USB memory stick. The Verion Digital Marker links to compatible surgical microscopes to display concurrently the reference and microscope images, allowing the surgeon to account for lateral and rotational eye movements. In addition, details from the Verion Reference Unit surgical plan can be overlaid on a computer screen or the physician's microscope view.

CONTRAINDICATIONS: The following conditions may affect the accuracy of surgical plans prepared with the Verion Reference Unit: a pseudophakic eye, eye fixation problems, a non-intact cornea, or an irregular cornea. In addition, patients should refrain from wearing contact lenses during the reference measurement as this may interfere with the accuracy of the measurements. The following conditions may affect the proper functioning of the Verion Digital Marker: changes in a patient’s eye between preoperative measurement and surgery, an irregular elliptic limbus (e.g., due to eye fixation during surgery, and bleeding or bloated conjunctiva due to anesthesia). In addition, the use of eye drops that constrict sclera vessels before or during surgery should be avoided.

WARNINGS: Only properly trained personnel should operate the Verion Reference Unit and Verion Digital Marker. Use only the provided medical power supplies and data communication cable. Power supplies for the Verion Reference Unit and the Verion Digital Marker must be uninterruptible. Do not use these devices in combination with an extension cord. Do not cover any of the component devices while turned on. The Verion Reference Unit uses infrared light. Unless necessary, medical personnel and patients should avoid direct eye exposure to the emitted or reflected beam.

PRECAUTIONS: To ensure the accuracy of Verion Reference Unit measurements, device calibration and the reference measurement should be conducted in dimmed ambient light conditions. Only use the Verion Digital Marker in conjunction with compatible surgical microscopes.

ATTENTION: Refer to the user manuals for the Verion Reference Unit and the Verion Digital Marker for a complete description of proper use and maintenance of these devices, as well as a complete list of contraindications, warnings and precautions.

Lensx® Laser +

LenSx® Laser

Caution:
United States Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner.

Indication:
The LenSx® Laser is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

Restrictions:

  • Patients must be able to lie flat and motionless in a supine position.
  • Patient must be able to understand and give an informed consent.
  • Patients must be able to tolerate local or topical anesthesia.
  • Patients with elevated IOP should use topical steroids only under close medical supervision.

Contraindications:

  • Corneal disease that precludes applanation of the cornea or transmission of laser light at
    1030 nm wavelength
  • Descemetocele with impending corneal rupture
  • Presence of blood or other material in the anterior chamber
  • Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the capsulotomy
  • Conditions which would cause inadequate clearance between the intended capsulotomy depth and the endothelium (applicable to capsulotomy only)
  • Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape
  • Corneal thickness requirements that are beyond the range of the system
  • Corneal opacity that would interfere with the laser beam
  • Hypotony or the presence of a corneal implant
  • Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease)
  • History of lens or zonular instability
  • Any contraindication to cataract or keratoplasty
  • This device is not intended for use in pediatric surgery

Warnings:
The LenSx® Laser System should only be operated by a physician trained in its use.

The LenSx® Laser delivery system employs one sterile disposable LenSx® Laser Patient Interface consisting of an applanation lens and suction ring. The Patient Interface is intended for single use only. The disposables used in conjunction with ALCON® instrument products constitute a complete surgical system. Use of disposables other than those manufactured by Alcon may affect system performance and create potential hazards.

The physician should base patient selection criteria on professional experience, published literature, and educational courses. Adult patients should be scheduled to undergo cataract extraction.

Precautions:

  • Do not use cell phones or pagers of any kind in the same room as the LenSx® Laser.
  • Discard used Patient Interfaces as medical waste.

AEs/Complications:

  • Capsulotomy, phacofragmentation, or cut or incision decentration
  • Incomplete or interrupted capsulotomy, fragmentation, or corneal incision procedure
  • Capsular tear
  • Corneal abrasion or defect
  • Pain
  • Infection
  • Bleeding
  • Damage to intraocular structures
  • Anterior chamber fluid leakage, anterior chamber collapse
  • Elevated pressure to the eye

Attention:
Refer to the LenSx® Laser Operator’s Manual for a complete listing of indications, warnings and precautions.

CENTURION®
Vision System +

CENTURION® Vision System Important Product Information

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.
As part of a properly maintained surgical environment, it is recommended that a backup IOL Injector be made available in the event the AutoSert® IOL Injector Handpiece does not perform as expected.

INDICATIONS:
The CENTURION® Vision System is indicated for emulsification, separation, irrigation and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation and intraocular lens injection. The AutoSert® IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal.
The AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert IOL Injector Handpiece is indicated for use with the AcrySof® lenses SN6OWF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

Warnings:
Appropriate use of CENTURION® Vision System parameters and accessories is important for successful procedures. Use of low vacuum limits, low flow rates, low bottle heights, high power settings, extended power usage, power usage during occlusion conditions (beeping tones), failure to sufficiently aspirate viscoelastic prior to using power, excessively tight incisions and combinations of the above actions may result in significant temperature increases at incision site and inside the eye, and lead to severe thermal eye tissue damage.
Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye. Ensure that tubings are not occluded or pinched during any phase of operation.
The consumables used in conjunction with Alcon instrument products constitute a complete surgical system. Use of consumables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards.

Optical theory suggest, that, high astigmatic patients (i.e. > 2.5 D) may experience spatial distortions. Possible toric IOL related factors may include residual cylindrical error or axis misalignments. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof® IQ Toric Cylinder Power IOLs.

Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof® Natural IOL and normal color vision. The effect on vision of the AcrySof® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45° C; use only sterile irrigating solutions such as BSS® or BSS PLUS® Sterile Intraocular Irrigating Solutions.

AEs/Complications:
Inadvertent actuation of Prime or Tune while a handpiece is in the eye can create a hazardous condition that may result in patient injury. During any ultrasonic procedure, metal particles may result from inadvertent touching of the ultrasonic tip with a second instrument. Another potential source of metal particles resulting from any ultrasonic handpiece may be the result of ultrasonic energy causing micro abrasion of the ultrasonic tip.

ATTENTION:
Refer to the Directions for Use and Operator’s Manual for a complete listing of indications, warnings, cautions and notes.

AcrySof® IQ Toric IOL+

ACRYSOF® IQ TORIC INTRAOCULAR LENSES IMPORTANT PRODUCT INFORMATION

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

INDICATIONS: The AcrySof® IQ Toric posterior chamber intraocular lenses are intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision.

WARNINGS/PRECAUTIONS: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Toric IOLs should not be implanted if the posterior capsule is ruptured, if the zonules are damaged, or if a primary posterior capsulotomy is planned. Rotation can reduce astigmatic correction; if necessary lens repositioning should occur as early as possible prior to lens encapsulation. All viscoelastics should be removed from both the anterior and posterior sides of the lens; residual viscoelastics may allow the lens to rotate.

Optical theory suggests that high astigmatic patients (i.e., > 2.5 D) may experience spatial distortions. Possible toric IOL related factors may include residual cylindrical error or axis misalignments. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof® IQ Toric Cylinder Power IOLs.

Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof® Natural IOL and normal color vision. The effect on vision of the AcrySof® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45° C; use only sterile irrigating solutions such as BSS® or BSS PLUS® Sterile Intraocular Irrigating Solutions.

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

Click here to view the AcrySof® IQ Toric IOL Directions for Use (DFU).

AcrySof® IQ ReSTOR® Multifocal IOL +

ACRYSOF® IQ RESTOR® FAMILY OF INTRAOCULAR LENSES IMPORTANT PRODUCT INFORMATION

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

INDICATIONS: The AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lens (IOL) is intended for primary implantation for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag.

WARNINGS/PRECAUTIONS: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Physicians should target emmetropia, and ensure that IOL centration is achieved. Care should be taken to remove viscoelastic from the eye at the close of surgery.

Some patients may experience visual disturbances and/or discomfort due to multifocality, especially under dim light conditions. As with other multifocal IOLs, visual symptoms may be significant enough that the patient will request explant of the multifocal IOL. Spectacle independence rates vary with all multifocal IOLs; as such, some patients may need glasses when reading small print or looking at small objects.

Clinical studies with the AcrySof® ReSTOR® lens indicated that posterior capsule opacification (PCO), when present, developed earlier into clinically significant PCO. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof® IQ ReSTOR® IOLs.

Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof® Natural IOL and normal color vision. The effect on vision of the AcrySof® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45° C; use only sterile irrigating solutions such as BSS® or BSS PLUS® Sterile Intraocular Irrigating Solutions.

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

Click here to view the AcrySof® IQ ReSTOR® +2.5 D IOL Directions for Use (DFU).

Click here to view the AcrySof® IQ ReSTOR® +3.0 D IOL Directions for Use (DFU).

ORA System® +

ORA SYSTEM WITH VERIFEYE+ TECHNOLOGY IMPORTANT PRODUCT INFORMATION

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

INTENDED USE: The ORA System uses wavefront aberrometry data in the measurement and analysis of the refractive power of the eye (i.e., sphere, cylinder and axis measurements) to support cataract surgical procedures.

CONTRAINDICATIONS: The ORA System is contraindicated for patients:

  • who have progressive retinal pathology such as diabetic retinopathy, macular degeneration or any other pathology that the physician deems would interfere with patient fixation;
  • who have corneal pathology such as Fuchs’, EBMD, keratoconus, advanced pterygium impairing the cornea or any other pathology that the physician deems would interfere with the measurement process;
  • whose preoperative regimen includes residual viscous substances left on the corneal surface such as lidocaine gel or viscoelastics;
  • with visually significant media opacity (such as prominent floaters or asteroid hyalosis) what will either limit or prohibit the measurement process; or
  • who have received retro or peribulbar block or any other treatment that impairs their ability to visualize the fixation light.

In addition, utilization of iris hooks during an ORA System image capture is contraindicated, because the use of iris hooks will yield inaccurate measurements.

WARNINGS AND PRECAUTIONS:

  • Significant central corneal irregularities resulting in higher order aberrations might yield inaccurate refractive measurements.
  • Post refractive keratectomy eyes might yield inaccurate refractive measurement.
  • The safety and effectiveness of using the data from the ORA System have not been established for determining treatments involving higher order aberrations of the eye such as coma and spherical aberrations.
  • The ORA System is intended for use by qualified health personnel only.
  • Improper use of this device may result in exposure to dangerous voltage or hazardous laser-like radiation exposure.
  • Do not operate the ORA System in the presence of flammable anesthetics or volatile solvents such as alcohol or benzene, or in locations that present an explosion hazard.

ATTENTION: Refer to the ORA System Operator’s Manual for a complete description of proper use and maintenance of the ORA System, as well as a complete list of contraindications, warnings and precautions.

VERION IMAGE GUIDED SYSTEM IMPORTANT PRODUCT INFORMATION

Verion Reference Unit and Verion Digital Marker

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

INTENDED USES: The Verion Reference Unit is a preoperative measurement device that captures and utilizes a high-resolution reference image of a patient's eye. In addition, the Verion Reference Unit provides pre-operative surgical planning functions to assist the surgeon with planning cataract surgical procedures. The Verion Reference Unit also supports the export of the reference image, preoperative measurement data, and surgical plans for use with the Verion Digital Marker and other compatible devices through the use of a USB memory stick. The Verion Digital Marker links to compatible surgical microscopes to display concurrently the reference and microscope images, allowing the surgeon to account for lateral and rotational eye movements. In addition, details from the Verion Reference Unit surgical plan can be overlaid on a computer screen or the physician's microscope view.

CONTRAINDICATIONS: The following conditions may affect the accuracy of surgical plans prepared with the Verion Reference Unit: a pseudophakic eye, eye fixation problems, a non-intact cornea, or an irregular cornea. In addition, patients should refrain from wearing contact lenses during the reference measurement as this may interfere with the accuracy of the measurements. The following conditions may affect the proper functioning of the Verion Digital Marker: changes in a patient’s eye between preoperative measurement and surgery, an irregular elliptic limbus (e.g., due to eye fixation during surgery, and bleeding or bloated conjunctiva due to anesthesia). In addition, the use of eye drops that constrict sclera vessels before or during surgery should be avoided.

WARNINGS: Only properly trained personnel should operate the Verion Reference Unit and Verion Digital Marker. Use only the provided medical power supplies and data communication cable. Power supplies for the Verion Reference Unit and the Verion Digital Marker must be uninterruptible. Do not use these devices in combination with an extension cord. Do not cover any of the component devices while turned on. The Verion Reference Unit uses infrared light. Unless necessary, medical personnel and patients should avoid direct eye exposure to the emitted or reflected beam.

PRECAUTIONS: To ensure the accuracy of Verion Reference Unit measurements, device calibration and the reference measurement should be conducted in dimmed ambient light conditions. Only use the Verion Digital Marker in conjunction with compatible surgical microscopes.

ATTENTION: Refer to the user manuals for the Verion Reference Unit and the Verion Digital Marker for a complete description of proper use and maintenance of these devices, as well as a complete list of contraindications, warnings and precautions.

LenSx® Laser

Caution:
United States Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner.

Indication:
The LenSx® Laser is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

Restrictions:

  • Patients must be able to lie flat and motionless in a supine position.
  • Patient must be able to understand and give an informed consent.
  • Patients must be able to tolerate local or topical anesthesia.
  • Patients with elevated IOP should use topical steroids only under close medical supervision.

Contraindications:

  • Corneal disease that precludes applanation of the cornea or transmission of laser light at
    1030 nm wavelength
  • Descemetocele with impending corneal rupture
  • Presence of blood or other material in the anterior chamber
  • Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the capsulotomy
  • Conditions which would cause inadequate clearance between the intended capsulotomy depth and the endothelium (applicable to capsulotomy only)
  • Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape
  • Corneal thickness requirements that are beyond the range of the system
  • Corneal opacity that would interfere with the laser beam
  • Hypotony or the presence of a corneal implant
  • Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease)
  • History of lens or zonular instability
  • Any contraindication to cataract or keratoplasty
  • This device is not intended for use in pediatric surgery

Warnings:
The LenSx® Laser System should only be operated by a physician trained in its use.

The LenSx® Laser delivery system employs one sterile disposable LenSx® Laser Patient Interface consisting of an applanation lens and suction ring. The Patient Interface is intended for single use only. The disposables used in conjunction with ALCON® instrument products constitute a complete surgical system. Use of disposables other than those manufactured by Alcon may affect system performance and create potential hazards.

The physician should base patient selection criteria on professional experience, published literature, and educational courses. Adult patients should be scheduled to undergo cataract extraction.

Precautions:

  • Do not use cell phones or pagers of any kind in the same room as the LenSx® Laser.
  • Discard used Patient Interfaces as medical waste.

AEs/Complications:

  • Capsulotomy, phacofragmentation, or cut or incision decentration
  • Incomplete or interrupted capsulotomy, fragmentation, or corneal incision procedure
  • Capsular tear
  • Corneal abrasion or defect
  • Pain
  • Infection
  • Bleeding
  • Damage to intraocular structures
  • Anterior chamber fluid leakage, anterior chamber collapse
  • Elevated pressure to the eye

Attention:
Refer to the LenSx® Laser Operator’s Manual for a complete listing of indications, warnings and precautions.

CENTURION® Vision System Important Product Information

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.
As part of a properly maintained surgical environment, it is recommended that a backup IOL Injector be made available in the event the AutoSert® IOL Injector Handpiece does not perform as expected.

INDICATIONS:
The CENTURION® Vision System is indicated for emulsification, separation, irrigation and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation and intraocular lens injection. The AutoSert® IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal.
The AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert IOL Injector Handpiece is indicated for use with the AcrySof® lenses SN6OWF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

Warnings:
Appropriate use of CENTURION® Vision System parameters and accessories is important for successful procedures. Use of low vacuum limits, low flow rates, low bottle heights, high power settings, extended power usage, power usage during occlusion conditions (beeping tones), failure to sufficiently aspirate viscoelastic prior to using power, excessively tight incisions and combinations of the above actions may result in significant temperature increases at incision site and inside the eye, and lead to severe thermal eye tissue damage.
Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye. Ensure that tubings are not occluded or pinched during any phase of operation.
The consumables used in conjunction with Alcon instrument products constitute a complete surgical system. Use of consumables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards.

Optical theory suggest, that, high astigmatic patients (i.e. > 2.5 D) may experience spatial distortions. Possible toric IOL related factors may include residual cylindrical error or axis misalignments. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof® IQ Toric Cylinder Power IOLs.

Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof® Natural IOL and normal color vision. The effect on vision of the AcrySof® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45° C; use only sterile irrigating solutions such as BSS® or BSS PLUS® Sterile Intraocular Irrigating Solutions.

AEs/Complications:
Inadvertent actuation of Prime or Tune while a handpiece is in the eye can create a hazardous condition that may result in patient injury. During any ultrasonic procedure, metal particles may result from inadvertent touching of the ultrasonic tip with a second instrument. Another potential source of metal particles resulting from any ultrasonic handpiece may be the result of ultrasonic energy causing micro abrasion of the ultrasonic tip.

ATTENTION:
Refer to the Directions for Use and Operator’s Manual for a complete listing of indications, warnings, cautions and notes.

ACRYSOF® IQ TORIC INTRAOCULAR LENSES IMPORTANT PRODUCT INFORMATION

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

INDICATIONS: The AcrySof® IQ Toric posterior chamber intraocular lenses are intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision.

WARNINGS/PRECAUTIONS: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Toric IOLs should not be implanted if the posterior capsule is ruptured, if the zonules are damaged, or if a primary posterior capsulotomy is planned. Rotation can reduce astigmatic correction; if necessary lens repositioning should occur as early as possible prior to lens encapsulation. All viscoelastics should be removed from both the anterior and posterior sides of the lens; residual viscoelastics may allow the lens to rotate.

Optical theory suggests that high astigmatic patients (i.e., > 2.5 D) may experience spatial distortions. Possible toric IOL related factors may include residual cylindrical error or axis misalignments. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof® IQ Toric Cylinder Power IOLs.

Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof® Natural IOL and normal color vision. The effect on vision of the AcrySof® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45° C; use only sterile irrigating solutions such as BSS® or BSS PLUS® Sterile Intraocular Irrigating Solutions.

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

Click here to view the AcrySof® IQ Toric IOL Directions for Use (DFU).

ACRYSOF® IQ RESTOR® FAMILY OF INTRAOCULAR LENSES IMPORTANT PRODUCT INFORMATION

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

INDICATIONS: The AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lens (IOL) is intended for primary implantation for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag.

WARNINGS/PRECAUTIONS: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Physicians should target emmetropia, and ensure that IOL centration is achieved. Care should be taken to remove viscoelastic from the eye at the close of surgery.

Some patients may experience visual disturbances and/or discomfort due to multifocality, especially under dim light conditions. As with other multifocal IOLs, visual symptoms may be significant enough that the patient will request explant of the multifocal IOL. Spectacle independence rates vary with all multifocal IOLs; as such, some patients may need glasses when reading small print or looking at small objects.

Clinical studies with the AcrySof® ReSTOR® lens indicated that posterior capsule opacification (PCO), when present, developed earlier into clinically significant PCO. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof® IQ ReSTOR® IOLs.

Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof® Natural IOL and normal color vision. The effect on vision of the AcrySof® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45° C; use only sterile irrigating solutions such as BSS® or BSS PLUS® Sterile Intraocular Irrigating Solutions.

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

Click here to view the AcrySof® IQ ReSTOR® +2.5 D IOL Directions for Use (DFU).

Click here to view the AcrySof® IQ ReSTOR® +3.0 D IOL Directions for Use (DFU).

ORA SYSTEM WITH VERIFEYE+ TECHNOLOGY IMPORTANT PRODUCT INFORMATION

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

INTENDED USE: The ORA System uses wavefront aberrometry data in the measurement and analysis of the refractive power of the eye (i.e., sphere, cylinder and axis measurements) to support cataract surgical procedures.

CONTRAINDICATIONS: The ORA System is contraindicated for patients:

  • who have progressive retinal pathology such as diabetic retinopathy, macular degeneration or any other pathology that the physician deems would interfere with patient fixation;
  • who have corneal pathology such as Fuchs’, EBMD, keratoconus, advanced pterygium impairing the cornea or any other pathology that the physician deems would interfere with the measurement process;
  • whose preoperative regimen includes residual viscous substances left on the corneal surface such as lidocaine gel or viscoelastics;
  • with visually significant media opacity (such as prominent floaters or asteroid hyalosis) what will either limit or prohibit the measurement process; or
  • who have received retro or peribulbar block or any other treatment that impairs their ability to visualize the fixation light.

In addition, utilization of iris hooks during an ORA System image capture is contraindicated, because the use of iris hooks will yield inaccurate measurements.

WARNINGS AND PRECAUTIONS:

  • Significant central corneal irregularities resulting in higher order aberrations might yield inaccurate refractive measurements.
  • Post refractive keratectomy eyes might yield inaccurate refractive measurement.
  • The safety and effectiveness of using the data from the ORA System have not been established for determining treatments involving higher order aberrations of the eye such as coma and spherical aberrations.
  • The ORA System is intended for use by qualified health personnel only.
  • Improper use of this device may result in exposure to dangerous voltage or hazardous laser-like radiation exposure.
  • Do not operate the ORA System in the presence of flammable anesthetics or volatile solvents such as alcohol or benzene, or in locations that present an explosion hazard.

ATTENTION: Refer to the ORA System Operator’s Manual for a complete description of proper use and maintenance of the ORA System, as well as a complete list of contraindications, warnings and precautions.