On February 21, 2007, the U.S. Food and Drug Administration (FDA) issued a Class I recall of the LADAR6000 Excimer Laser System for CustomCornea®. The product is used for LASIK and wavefront-guided LASIK treatment for the reduction or elimination of mild to moderate nearsightedness and farsightedness.

The LADAR6000 Excimer Laser has caused corneal abnormalities called “central islands.” In addition, the laser has also decreased visual sharpness. The “central islands” are not correctable with lasers, and the decreased visual sharpness is not correctable with glasses or contact lenses.

Class I recalls are the most serious type of FDA recalls of medical devices and involve cases where there is a reasonable certainty that use of the product may cause serious personal injury. Patients with questions can call Alcon Refractive Horizon, Inc., at 1-877-523-2784.

Source: U.S. Food and Drug Administration, “Class 1 Recall: Alcon Refractive horizons, Inc. LADAR6000 Excimer Laser System,”, February 21, 2007.