Company: VISX Inc., a Subsidiary of AMO, Inc.
Date of Enforcement Report 10/15/2008
Class:ll
PRODUCT
AMO WaveScan WaveFront System Version 3.90/3.901, Part Number 0070-1478. The device is used in conjunction with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems, which are indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. The WaveScan System is a diagnostic instrument intended for the automated measurement, analysis and recording of refractive errors of the eye. Recall # Z-2310-2008
REASON
Inaccurate measurements may be generated by the device, which could result in improper treatment and deterioration of patient eyesight.
RECALLING FIRM/MANUFACTURER
Recalling Firm: VISX Inc., a Subsidiary of AMO, Inc., Santa Clara, CA, by letter on June 9, 2008.
Manufacturer: AMO Manufacturing USA, LLC, Milpitas, CA. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
160 software kits
DISTRIBUTION
Nationwide
