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U.S. Department of Health and Human Services

Safety

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Alcon Refractive Horizons LADAR6000 Excimer Laser System

Audience: Ophthalmologists, patients

[Posted 06/05/2007] Alcon Refractive Horizons and FDA notified healthcare professionals and patients of a Class I Recall of the LADAR6000 Excimer Laser System for CustomCornea algorithm for myopia with astigmatism (M3) and myopia without astigmatism (A7). This system is used for LASIK and wave-front guided LASIK treatment for the reduction or elimination of mild to moderate nearsightedness (myopia) and farsightedness (hyperopia) with or without astigmatism or for mixed astigmatism in patients who are 21 years of age or older with documented stability of refraction for the prior 12 months.

The product was recalled because use of the Alcon Refractive Horizons CustomCornea algorithm for myopia with and without astigmatism with the LADAR6000 Excimer Laser caused corneal abnormalities ("central islands") and decreased visual sharpness (visual acuity) in patients. These "central islands" may not be correctable with lasers and the decrease in visual acuity may not be correctable with glasses or contact lenses. Patients with questions should call the company at 1-877-523-2784.

[June 05, 2007 - Recall Notice - FDA]