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.
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.
The software upgrade can cause the laser system to make cuts on the plastic hemisphere during daily alignment verification that don't match the intended cuts displayed on the treatment screen. This mismatch could lead to incorrect surgical incisions during cataract procedures, potentially causing complications.
Patients undergoing cataract surgery using the recalled OptiMedica Catalys Precision Laser Systems with specific serial numbers and software versions are affected. Surgeons and surgical teams using these systems are at the highest risk of potential surgical errors.
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.
Look for the product label on the system with specific serial numbers listed in the recall notice.
The problematic software version is cOS 5.00.33.
The affected serial numbers are 44109015, 44106215, 44107315, 44065613 (US version) and 46120916, 46123116, 46124617, 46131418, 46131618 (international version).
The software issue can cause cuts on the plastic hemisphere during daily alignment verification to not match the intended cuts shown on the treatment screen, which may lead to incorrect surgical incisions during cataract procedures.
We’ve drafted a message you can send OptiMedica to request your refund or repair — edit it as you like.
Subject: Recall Z-0066-2019 — OptiMedica OptiMedica Hello, I own a OptiMedica that is covered by recall Z-0066-2019 from OptiMedica. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
