Abbott Medical Optics, Inc. recalls OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indi…
- Recall date
- February 20, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1515-2015
- FDA classification
- Class II
- Brand / firm
- Abbott Medical Optics, Inc.
- Sold / distributed
- 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, Turke…
Why it was recalled
Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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