Reported Oct 10, 2018 · Terminated
OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers:…
Johnson & Johnson Surgical Vision Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Johnson & Johnson Surgical Vision Inc · 510 Cottonwood Dr · Milpitas, CA · 95035-7403
Is this the product you have?
- OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33
- Product Label for Serial Numbers
441090154410621544107315and 44065613 label states "Manufactured
- forOptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089
- USA Product Label for Serial Numbers
46120916461231164612461746131418and 46131618 label states "Manufactured
- forOptiMedica 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
- Lot codes and dates
- ModelCatalys Precision Laser System
- CE 0044Catalys-U (US
- version) Serial Numbers44065613 - software cOS 5.00.33 install date 4/27/2018 46131618 - software cOS 5.00.33 install date 4/23/2018 46131418 - software cOS 5.00.33 install date 4/30/2018 44107315 - software cOS 5.00.33 install date 5/1/2018 46120916 - software cOS 5.00.33 install date 4/23/2018 46123116 - software cOS 5.00.33 install date 5/2/2018 44106215 - software cOS 5.00.33 install date 5/3/2018 Catalys-I (International
- version) Serial Number44109015 - software cOS 5.00.33 install date 5/1/2018 46124617 - software cOS 5.00.33 install date 5/3/2018
- Amount recalled
- 9
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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