Recall Z-1515-2015 ยท OOE Ophthalmic Femtosecond Laser
Abbott Medical Optics, Inc.
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.
| Date | Apr 23, 2015 (initiated Feb 20, 2015) |
| Status | Terminated |
| Reason | Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation. |
| Root cause | Device Design |
| 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. |
| Quantity | 202 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141079 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM Optimedica Corporation, Sep 11, 2014 |