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Abbott Medical Optics, Inc. recalls OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: I
Recalled April 29, 2015 · FDA recall Z-1515-2015 · Abbott Medical Optics
Hazard
Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation. · FDA Class II
Units
202
Sold at
Worldwide Distribution - US Nationwide and the countries of, Canada, Germany, Switzerland, Australia, Spain, Japan, Great Britain, France, Netherlands, Austria, Singapore, South Korea, India, Thailand, Colombia, Ecuador, Italy, Brazil, Egypt, Tunsia, Belgium, Mexico, Greece, Guatemala, Chile, Turkey, Peru, Hong Kong, Saudi Arabia, Bangladesh, and Dominican Rep.
Description
Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation.
Product
OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.
Manufacturer(s)
Abbott Medical Optics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →