Company: Visx Incorporated
Date of Enforcement Report 8/27/2008
Class:ll
PRODUCT
Excimer Laser System; WaveScan WaveFront System, Software Version 3.65, for use with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems. System is a diagnostic instrument intended for the automated measurement; analysis and recording of refractive errors and wavefront aberrations to the target shape and then generates the commands for the VISX STAR laser to create the target shape on the cones. Part Numbers 0070-0150, 0070-0150R, 0070-1006, 0070-1006R, and 0070-1478; Recall # Z-1695-2008
REASON
Firm became aware of a significant overcorrection in one eye of a patient who had received a wavefront-guided LASIK treatment at a facility in Germany. The probability of a recurrence of this error was determine to be extremely remote, however to prevent re-occurrence of this type of incident a software update was developed.
RECALLING FIRM/MANUFACTURER
Visx Incorporated, a subsidiary of AMO, Inc., Santa Clara, CA, by letter on November 27, 2006. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
1,310 units
DISTRIBUTION
Nationwide and Internationally
