OptiMedica Catalys Precision Laser System Software Recall for Incorrect Parameters
OptiMedica is recalling Catalys Precision Laser Systems with software version 3.00.05 because a software anomaly may provide incorrect cataract surgery parameters.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 used in surgery where incorrect parameters could lead to harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
OptiMedica Corporation is recalling the Catalys Precision Laser System, specifically units running software version 3.00.05. The recall covers 171 units distributed worldwide, including in the United States, Germany, Switzerland, Australia, and other countries.
The recall is due to a software anomaly that may result in incorrect parameters being provided for cataract incision surgeon templates. Additionally, the anomaly may cause both eyes to have the same parameters. The device is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
Healthcare providers and patients should contact OptiMedica Corporation for further instructions on how to address the software issue.
The recalled product
- Product
- Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
- Manufacturer
- Optimedica Corporation
- Affected units
- 171
Distribution
Distributed nationwide across the United States.
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