Company: Visx, Inc
Date of Enforcement Report 1/30/2008
Class:ll
PRODUCT
Advanced Medical Optics (AMO), VISX WaveScan WaveFront System (software). Part Number 0070-1478, Recall # Z-0365-2008
REASON
Erroneous Treatment Calculations – Two software caused errors; in combination, in the WaveScan System Software, will result in an erroneous treatment calculation (overcorrection) in patients. (1) Installation of software for a certain brand of computer (Dedicated Computing LLC) can cause a software registry setting for an algorithm that identifies image reflection to be erroneously set in the “off” position upon installation on these specific computers, and (2) Software error in the WaveScan System application produces erroneous treatment calculations.
RECALLING FIRM/MANUFACTURER
Visx, Inc., Santa Clara, CA, by letter on May 30, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
329 systems
DISTRIBUTION
Nationwide and Internationally
