Home / Recalls / Medical Devices
Optimedica Corporation recalls Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05
Recalled June 3, 2015 · FDA recall Z-1683-2015 · Optimedica
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. · FDA Class II
Units
171 distributed Worldwide
Sold at
Worldwide Distribution - US Nationwide, Germany, Switzerland, Australia, Spain, Japan, Great Britain, France, Netherlands, Austria, Singapore, South Korea, India, Brazil, Italy, Belgium, Egypt, Colombia, Hong Kong, and Canada.
Description
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.
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(s)
Optimedica Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →