Wavelight plus

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

DESCRIPTION AND CHARACTERISTICS:

The WaveLight^® Plus laser systems is a non-contact ophthalmic diagnostic device designed to capture Scheimpflug images of the anterior segment of the eye, which includes the cornea, pupil, anterior chamber, and lens of the eye. Furthermore, it provides the axial dimensions of the eye using the technology of coherence interferometry. It can also measure the optical aberrations of the eye by applying Hartman-Shack wavefront technology

INDICATION:

The WaveLight^® Plus laser systems is indicated for screening and diagnosis of adult patients who may undergo a customized photorefractive treatment with the WaveLight^® Plus laser systems.

The WaveLight EX500 laser system in conjunction with WaveLight^® Plus Sightmap is indicated for use in INNOVEYES Laser Assisted In-Situ Keratomileusis (“wavelight plus”1 LASIK) treatments:

• for the reduction or elimination of myopia or myopia with astigmatism, in eyes with spherical equivalent (SE) more than -1.00 and up to -9.00 diopters (D), with up to -8.00 D of spherical component (in minus cylinder format) and up to -3.00 D of astigmatic component at the spectacle plane, based on the INNOVEYES Sightmap Measured Refraction
• in patients with magnitude of the spherical equivalent (SE) difference between the Manifest Refraction (MRSE) and the Sightmap measured refraction SE being less than 0.75 D,
• in patients who are 18 years of age or older, and
• for patients with documentation of a stable manifest refraction defined as ≤ 0.5 D preoperative spherical equivalent shift over one year prior to surgery.

CONTRAINDICATIONS:

If you have any of the following situations or conditions, it is not recommended to have an examination with the WaveLight^® Plus laser systems.

• Patients with open wounds and sores getting in contact with the head rest must not be examined.

There are no other known contraindications to the use of the WaveLight^® Plus laser systems when used according to its approved indications.

TARGET PATIENT POPULATION:

The targeted patient population are patients which are selected for ophthalmic diagnosis consistent with the indications for use of the WaveLight^® Plus laser systems.

INTENDED USERS:

The WaveLight^® Plus laser systems may only be used by specially trained physicians, medical staff and optometrists who are well versed in its diagnostic abilities and possible dangers.

WARNINGS / PRECAUTIONS:

• Contact lens wearers must discontinue wearing hard or gas permeable lenses for at least 3 weeks and soft lenses for at least 1 week prior to examination.
• The examination takes place in a darkened room or with the help of a dark cloth covering the WaveLight^® Plus laser systems and the patient’s head.
• The patient must be able to sit in an upright and comfortable position.
• The patient must be able to fixate steadily.
• Patients should not wear makeup at the day of examination.
• Avoid using eye-drops before examination. It may impact the diagnostic results and should be reported to the surgeon.
• Taking medication with influence on the hormonal balance can affect the consistency of the cornea.
• Results may be influenced by pregnancy and nursing. Hormonal changes can affect the consistency of the cornea.
• This device can cause flammable materials to ignite or explode
• Use of the controls or adjustments or performance procedures other than those specified in the user manual may result in hazardous radiation exposure.

MODE OF ACTION

The mode of action of the WaveLight^® Plus laser systems is through the screening and diagnosis of anterior segment of the eye for planning custom refractive surgery treatments with the intent of improving vision.

STORAGE CONDITIONS

Store at -10-55°C (14-131°F).

ATTENTION: Refer to the Directions for Use labeling for a complete list of warnings, precautions, and adverse reactions.