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Important Product Information for WaveLight® Products
WaveLight® Excimer Lasers are prescription medical devices that are approved for use in performing laser-assisted in situ keratomileusis (LASIK) to correct certain kinds of nearsighted (myopia), farsighted (hyperopia), and astigmatism. Only doctors who have been trained in laser refractive surgery (including laser calibration and operation) should use an WaveLight® Excimer Laser.
You should not undergo LASIK surgery if you are pregnant or nursing; if you have a collagen vascular, autoimmune or immunodeficiency disease; if you show signs of keratoconus or any other condition that causes a thinning of your cornea; or if you are taking isotretinoin (Accutane*) or amiodarone hydrochloride (Cordarone*). The most common risks of LASIK vision correction surgery with refractive lasers include dry eye syndrome; the possible need for glasses or contact lenses after surgery; visual symptoms including halos, glare, starbursts, and double vision; and loss of vision.
Talk to your doctor and review the appropriate WaveLight® Excimer Laser Patient Information Booklet for your condition to learn more about the potential risks and benefits for laser refractive surgery. For further information, please refer to the additional Important Product Information on this site, or FDA’s web page on LASIK surgery.
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