Company: Johnson & Johnson Surgical Vision Inc
Date of Enforcement Report 10/10/2018
Class II:
PRODUCT
OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33
Recall Number: Z-0066-2019
REASON
Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown on the treatment overlay screen on the system GUI.
RECALLING FIRM/MANUFACTURER
Johnson & Johnson Surgical Vision Inc. Milpitas, CA on 5/9/2018
Voluntary: Firm Initiated
VOLUME OF PRODUCT IN COMMERCE
9
DISTRIBUTION
US Distribution to states of: CO, GA, IL, MD including Puerto Rico and internationally to countries of: Austria and Germany