Company: Alcon Laboratories, Inc.,
Date of Enforcement Report:6/28/2006
Class:lI

PRODUCT
LADARVision Excimer Laser System, Recall # Z-1147-06

REASON
A software error associated with the use of the Measuring Mode (ruler tool) on the LADARVision4000 Excimer Laser Systems. Use of this feature after alignment of the horizontal reference line will negate compensation for cyclotorsion on Custom Cornea procedures, possibly adversely affecting clinical outcomes.

CODE
CustomCornea software only. System serial numbers with prefix L4N and L4U

RECALLING FIRM/MANUFACTURER
Alcon Laboratories, Inc., Orlando, FL, by letter dated August 1, 2005. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
436 devices

DISTRIBUTION
Nationwide and Internationally