Class 1 Recall: Alcon Refractive Horizons, Inc. LADAR6000™ Excimer Laser System

LADAR6000™ Excimer Laser System for CustomCornea® algorithm for myopia with astigmatism (M3), and myopia without astigmatism (A7)

The LADAR6000™ Excimer Laser System is used for LASIK and wavefront-guided LASIK treatment for the reduction or elimination of mild to moderate nearsightedness (myopia) and farsightedness (hyperopia) with or without astigmatism and for mixed astigmatism in patients who are 21 years of age or older with documented stability of refraction for the prior 12 months. The cornea is the clear (transparent) dome-shaped front portion of the outer covering of the eye.

The use of Alcon Refractive Horizon, Inc.’s CustomCornea® algorithm for myopia with astigmatism (M3) and myopia without astigmatism (A7) with the LADAR6000™ Excimer Laser caused corneal abnormalities (“central islands”). It also resulted in decreased visual sharpness (visual acuity). These “central islands” may not be correctable with lasers. Additionally, the decrease in visual acuity may not be correctable with glasses or contact lenses.

This recall is limited to the CustomCornea® algorithms described above, and not the entire LADAR6000™ device.

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. Eighteen are held in Alcon’s possession and two are being held by the freight handler.

Alcon first notified doctors on February 21, 2007 of the problem via letter and recall notice, directing doctors to stop using the CustomCornea® algorithm for myopia with astigmatism (M3) and myopia without astigmatism (A7).

On May 11, 2007, Alcon updated doctors in a letter stating that Alcon will deactivate their device’s ability to perform CustomCornea® Myopia and CustomCornea® Myopia with astigmatism procedures. Alcon has completed deactivation of these two algorithms in all LADAR6000™ lasers in service in the U.S.

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.
Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online: www.fda.gov/MedWatch/report.htm
  
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
  
• FAX: 1-800-FDA-0178