The LADAR6000 excimer laser system for CustomCornea (Alcon, Fort Worth, Texas) algorithms for myopia with (M3) and without astigmatism (A7) have been recalled, according to the Food and Drug Administration (FDA).
According to the recall notice sent out last week to healthcare practitioners, the algorithms resulted in corneal abnormalities (including central islands) and decreased visual acuity. The central islands “may not be correctable with lasers and the decrease in visual acuity may not be correctable with glasses or contact lenses.”

The recalling firm, Alcon Refractive Horizons (Orlando, Fla.) noted the recall is limited only to the CustomCornea algorithms described, not the entire device. From August 2005 through February 2007, the company distributed 102 units worldwide with about 89 of those units distributed in the United States. Alcon first notified physicians of the problem via letter and recall notice in February 2007. In May Alcon updated doctors in a letter stating its intention to deactivate the two algorithms.

Source: www.eyeworld.org - Weekly News, Volume 12, Number 14, June 11, 2007