LADAR6000 Excimer Laser Eye Surgery System recall

08/06/2007

Alcon Refractive Horizons Inc and the FDA (Food and Drug Administration authority for the US) have notified healthcare professionals and patients of a Class I Recall of the LADAR6000 Excimer Laser System for CustomCornea procedures.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that, should this particular malfunction occur, use of the affected product may cause serious injury or death if the problem is not corrected.

Alcon a global company with headquarters in Switzerland, issued a recall after reports its systems caused corneal abnormalities (central islands) and decreased visual sharpness. These central islands may not be correctable with lasers and the decrease in visual sharpness may not be correctable with glasses or contact lenses.

This recall is however limited to the CustomCornea system and not the entire LADAR600 range. The device is used in a CustomCornea procedures for long or short sightedness, with or without astigmatism (blurring of images), in both LASIK and wavefront guided LASIK surgery.

From August 17, 2005, through February 21, 2007, Alcon Refractive Horizon, Inc. distributed 102 units worldwide with approximately 89 of those units distributed in the U.S. Alcon first notified doctors on February 21, 2007 of the problem via letter and recall notice, directing doctors to stop using the CustomCornea. On May 11, 2007, Alcon updated doctors in a letter stating that Alcon will deactivate their device's ability to perform CustomCornea.

If you have been affected by the product mentioned you might be entitled to claim compensation. Fill in our online claims form or see our Laser Eye Surgery Claims page for more information.