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.
FDA Recall Z-1515-2015 · Posted 2015-04-23
Recalling FirmAbbott Medical Optics, Inc.
Recall StatusTerminated
Product CodeOOE
Date Initiated2015-02-20
Date Terminated2019-07-09
Product Quantity202
Reason for Recall
Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation.
Firm Action
Abbott Medical Optics (AMO) sent an Advisory Notice letter dated March 5, 2015 via FedEx overnight delivery to each Catalys Precision Laser System owner. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the attached Acknowledgement Form. For questions contact AMO Technical Support at 1-855-662-0911.
Root Cause
Device Design
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.