CLASS II Device recall · Reported 10 Oct 2018 · FDA Enforcement Report
OptiMedica Catalys Precision Laser System, CE 0044 containing recalled
Johnson & Johnson Surgical Vision is recalling OptiMedica Catalys Precision Laser System, CE 0044 containing, distributed in Colorado, Georgia, Illinois, Maryland, Puerto Rico. The recall was initiated on 9 May 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0066-2019
- FDA event ID
- 80849
- Recalling firm
- Johnson & Johnson Surgical Vision, Milpitas, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 May 2018
- FDA classified
- 3 Oct 2018
- Reported
- 10 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Foreign Material
- Device type
- Medical Software
Timeline
| 9 May 2018 | Recall initiated by company | |
| 3 Oct 2018 | Classified by FDA | +147 days |
| 10 Oct 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
US Distribution to states of: CO, GA, IL, MD including Puerto Rico and internationally to countries of: Austria and Germany.
Questions about this recall
Why was it 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.
Which lots are affected?
Model: Catalys Precision Laser System, CE 0044: Catalys-U (US version) Serial Numbers: 44065613 - 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 Number: 44109015 - software cOS 5.00.33 install date 5/1/2018 46124617 - software cOS 5.00.33 install date 5/3/2018
Where was it sold?
US Distribution to states of: CO, GA, IL, MD including Puerto Rico and internationally to countries of: Austria and Germany.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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