Company: AMO Manufacturing USA, LLC,
Date of Enforcement Report 3/30/2011
Class ll:
PRODUCT
AMO brand WaveScan WaveFront System, OPM software versions 3.67 and 3.67, Part Number: 0070-1531, Catalog Numbers: 0070-1664, 0070-1649, 0070-1654: Version 3.67 0070-1721: Version 3.671 0070-1662: Version 3.67, US version; 0070-1668; IVersion 3.67 International version. The WaveScan WaveFront System is a class III accessory device used in conjunction with the VISX? STAR S4 and STAR S4 IRTM Excimer Laser Systems, which are indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. The WaveScan WaveFront System is a diagnostic instrument intended for the automated measurement, analysis, and recording of refractive errors of the eye. The WaveScan System software uses the diagnostic data of the eye’s refractive errors and wavefront aberrations to calculate the target treatment shape and then generates the commands for the VISX STAR laser to create the target shape on the cornea. Recall # Z-1374-2011
REASON
The failure to comply with Minimum System Requirements, increased system errors could result, and a mistreated treatment table (incorrect LASIK refractive treatment) could result.
RECALLING FIRM/MANUFACTURER
AMO Manufacturing USA, LLC, Milpitas, CA, by letter starting July 15, 2010. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1010 units Nationwide; 656 units Internationally
DISTRIBUTION
Nationwide and Internationally
