Information Regarding LADAR6000™ Excimer Laser Recall

On February 21, 2007, Alcon initiated a voluntary action which resulted in the disabling of the capability to perform the CustomCornea® Myopia, CustomCornea® Myopia with Astigmatism, and CustomCornea® Mixed Astigmatism indications using the LADAR6000™ Excimer Laser system. The FDA has classified Alcon's actions as a Class I recall.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=51005

As a result, the following letter was sent to all users of the LADAR6000™ Excimer Laser.

Alcon Letter to Doctors

We continue to be in contact with the FDA as we work toward a resolution of this issue.

If you have had a procedure on a LADAR6000™ Excimer Laser and have questions or concerns about your treatment or outcome, you should consult with your eye care professional.