This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: WaveLight ALLEGRETTO WAVE™ Excimer Laser System
Manufacturer: WaveLight Laser Technologie AG
Address: Am Wolfsmantel 5, 91058 Erlangen, Germany
Approval Date: October 7, 2003
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/p020050a.pdf
What is it? This device is a refractive excimer laser system that uses invisible ultraviolet (UV) light pulses to remove precise amounts of corneal tissue from the eye to reduce or eliminate nearsightedness and astigmatism. An eye tracker detects the position of the eye and aligns the laser pulse with the cornea.
How does it work? The laser system treats nearsightedness by removing tissue from the center of the cornea to flatten it. It treats astigmatism by flattening the central cornea by different amounts and at different orientations to correct for uneven focus.
When is it used? The device is intended to treat patients who have nearsightedness up to -12 diopters (D) and astigmatism up to -6 D, who are 18 years of age or older, and whose eyesight has been stable (by =.5 D) for the year prior to the pre-operative examination.
What will it accomplish? Excimer laser treatment is intended to reduce or eliminate nearsightedness and/or astigmatism. Side effects may include glare from bright lights, halos (rings around lights), light sensitivity, night driving glare, and visual fluctuation. Patients treated with excimer lasers may need reading glasses at earlier ages than usual.
When should it not be used? The system should not be used on patients who
- are pregnant or nursing;
- who have a collagen vascular, autoimmune or immunodeficiency disease;
- who show signs of keratoconus (an eye disorder in which there is thinning of the cornea that results in blurred or distorted images); or
- who are taking medications with ocular side effects (such as Accutane® or Cordarone®).
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p020050