FDA-Device2015-04-29Class II
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.
Abbott Medical Optics, Inc.
Hazard
Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation.
Sold states
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.
Affected count
202
Manufactured in
510 Cottonwood Dr, Milpitas, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1515-2015Don't want to check this manually?
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