Johnson & Johnson Surgical Vision Inc recalls OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44…

Recall date

May 9, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0066-2019

FDA classification

Class II

Brand / firm

Johnson & Johnson Surgical Vision Inc

Sold / distributed

US Distribution to states of: CO, GA, IL, MD including Puerto Rico and internationally to countries of: Austria and Germany.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product Label for Serial Numbers: 46120916; 46123116, 46124617; 46131418, and 46131618 label states "Manufactured for: OptiMedica Corporation 510 Cottonwood Drive Milpitas, CA 95035 USA The Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.