OptiMedica Catalys Precision Laser System Recalled for Software Alignment Failures
Johnson & Johnson is recalling nine Catalys Precision Laser Systems because a software upgrade causes alignment verification cuts to mismatch the intended treatment overlay.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that could impact surgical accuracy, but the source text does not report any illnesses or injuries, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Johnson & Johnson Surgical Vision Inc is recalling nine units of the OptiMedica Catalys Precision Laser System, CE 0044, containing software cOS 5.00.33. The recall involves specific serial numbers for both the US version (Catalys-U) and the international version (Catalys-I). The affected devices are indicated for use in cataract surgery for the removal of the crystalline lens, including procedures such as anterior capsulotomy and phacofragmentation.
The recall is due to a software upgrade that exhibits failures when executing the Daily Alignment Verification (DAV). Specifically, cuts made on the plastic hemisphere during the DAV do not match the intended cuts shown on the treatment overlay screen on the system's graphical user interface (GUI). This discrepancy could affect the accuracy of the laser system's alignment verification.
The affected units were distributed in the United States to Colorado, Georgia, Illinois, and Maryland, including Puerto Rico, as well as internationally to Austria and Germany. The source text does not report any illnesses or injuries associated with this recall. Users of these devices should contact Johnson & Johnson Surgical Vision Inc for further instructions regarding the software issue.
The recalled product
- Product
- 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 La
- Manufacturer
- Johnson & Johnson Surgical Vision Inc
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model: Catalys Precision Laser System
Distribution
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