Use cautionMedical device recall · FDA · Published May 9, 2018
OptiMedica Catalys Laser System Software Issue: DAV Cuts Mismatch Risk
Johnson & Johnson recalls OptiMedica Catalys Precision Laser Systems with specific software versions due to potential mismatch in plastic hemisphere cuts during daily alignment verification, affecting cataract surgery procedures.
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.
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Contact the company
📍Recalling firmJohnson & Johnson Surgical Vision Inc510 Cottonwood Dr · Milpitas, CA 95035-7403
✎ GovInfoNow plain-language explainer
Johnson & Johnson is recalling OptiMedica Catalys Precision Laser Systems with software version cOS 5.00.33. This software can cause cuts on the plastic hemisphere during daily alignment verification to not match the intended cuts shown on the treatment screen, which could lead to surgical errors. Read more at govinfonow.com/recall/71157-optimedica-catalys-laser-system-software-issue-dav-cuts-mismatch-risk.
“OptiMedica Catalys Laser System Software Issue: DAV Cuts Mismatch Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71157-optimedica-catalys-laser-system-software-issue-dav-cuts-mismatch-risk. Based on FDA recall #Z-0066-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0066-2019%22&limit=1).
Johnson & Johnson Surgical Vision, Inc. recalled the OptiMedica Catalys Precision Laser System containing software cOS 5.00.33 due to a Class II hazard, according to the FDA on May 9, 2018. The recall affects nine units distributed in the U.S., Puerto Rico, Austria, and Germany.
How to tell if you have it
Brand: OptiMedica
Product: Catalys Precision Laser System, CE 0044 with software cOS 5.00.33
The 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.
Context
GovInfoNow's records show Johnson & Johnson Surgical Vision, Inc. has 14 other recalls on record since June 21, 2018. Other recent recalls of similar products include HEALON Products for Corneal Injury Risk (July 31, 2026), Irrigation Sleeves: Risk of Insufficient Flow During Eye Surgery (March 14, 2024), and TECNIS Toric II IOLs with Angle Issue (December 12, 2023). Other recent recalls of similar products include Da Vinci Surgical System: Software Error May Cause Instrument Failure (November 7, 2025), Da Vinci 5 Surgical System Software Error May Cause Monitor Content Loss (November 17, 2025), and Daavlin Photera 600 UV Lamp: Incorrect UV Output Calibration Risk (March 5, 2026).
How to tell if you have this one
Check for the product label on the system with serial numbers: 44109015, 44106215, 44107315, 44065613 for the US version, or 46120916, 46123116, 46124617, 46131418, 46131618 for the international version. The system was manufactured with software cOS 5.00.33 installed on specific dates.
Brand
OptiMedica
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the product label on the system with specific serial numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed in 4 states and Puerto Rico, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US Distribution to states of: CO, GA, IL, MD including Puerto Rico and internationally to countries of: Austria and Germany.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Colorado, Georgia, Illinois, Maryland, Puerto Rico.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0066-2019 (May 9, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0066-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.