FDAFebruary 20, 2015device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parameters provided for cataract incision surgeon templates and both eyes have the same parameters.
What to do
FDA enforcement status: Terminated
Brands named
optimedica
Recall history
No related federal recalls on record for this brand yet.
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