Recall Z-1683-2015 ยท OOE Ophthalmic Femtosecond Laser
Optimedica Corporation
Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
| Date | May 28, 2015 (initiated Feb 20, 2015) |
| Status | Terminated |
| Reason | Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parameters provided for cataract incision surgeon templates and both eyes have the same parameters. |
| Root cause | Software design |
| Action | Abbott sent an Advisory Notice dated March 5, 2015, vis Fed Ex overnight to all affected customers. Out of State accounts will be notified through their distributor after letters are translated into local language. Recall notification letters advise customers of issue with CATALYS System using software version 3.00.05. The letter actually covers two issues, the cataract templates being the same for both eyes, and a loss of suction during treatment that may result in scoring the cornea. In both cases the issue is explained and users are advised to use mitigation listed to prevent injury. AMO |
| Quantity | 171 distributed Worldwide |
| Distribution | Worldwide Distribution - US Nationwide, Germany, Switzerland, Australia, Spain, Japan, Great Britain, France, Netherlands, Austria, Singapore, South Korea, India, Brazil, Italy, Belgium, Egypt, Colombia, Hong Kong, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141079 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM Optimedica Corporation, Sep 11, 2014 |