Recall – Catalys Precision Laser System

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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.