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 10, 2003
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030008a.pdf
What is it? The WaveLight ALLEGRETTO WAVE™ is a refractive excimer (heatless) laser system. It uses invisible ultraviolet (UV) light pulses to remove precise amounts of corneal tissue (the transparent outer coat of the eye that helps focus light to create an image) from the eye to reduce or eliminate farsightedness and astigmatism (distorted vision).
How does it work? The laser system treats farsightedness by removing tissue from the outer areas of the cornea to make it steeper. It treats astigmatism by flattening the central cornea by different amounts and at different locations to correct uneven focus.
When is it used? The laser system is intended for the LASIK (Laser-Assisted in Situ Keratomileusis) treatment of patients who:
- have farsightedness up to +6.0 diopters (D) and astigmatism up to 5 D with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D,
- are 18 years of age or older, and
- have had stable eyesight for the year prior to the pre-operative examination.
What will it accomplish? Excimer laser treatment is intended to reduce or eliminate farsightedness 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 an earlier age than usual.
When should it not be used? The laser system should not be used on patients who:
- are pregnant or nursing,
- have a collagen vascular disease (such as rheumatoid arthritis or scleroderma),
- have an autoimmune or immunodeficiency disease (such as AIDS or cancer),
- show signs of keratoconus (an eye disorder in which there is a thinning of the cornea that results in blurred or distorted vision), or
- are taking medications with visual 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=P030008