Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Recalled by Optimedica Corporation Due to Potential for unexpected heating of the transformer mounting...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Optimedica Corporation directly.
Affected Products
Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I 200-240V ~, 50/60 Hz, 15A, (2) 15A Resettable CB: Tested and complies with FCC Part 15 Class A. OptiMedica 1310 Moffett Park Drive Sunnyvale, CA 94089 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
Quantity: 78 (39 in US, 39 internationally)
Why Was This Recalled?
Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the subsequent melting of a non-slip computer shelf mat, which may manifest an odor and visible smoke.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Optimedica Corporation
Optimedica Corporation has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report