Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 The

FDA device recall Z-1683-2015 · posted 2015-05-28 · Terminated

Recall details

Recalling firm

Optimedica Corporation

Reason for recall

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.

Action taken

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 is developing an update to software that will correct these issues and users will be advised when it is available for installation. All users of the device should be made aware of the issues and each surgeon is requested to sign the acknowledgement form to verify their receipt and understanding. The acknowledgement for should be returned to Abbott Medical Optics per instructions. Questions in the US may be directed to AMO Technical support at 1-855-662-0911.

Root cause

Software design

Status

Terminated

Product code

OOE

Quantity affected

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, Colomb

Date initiated

2015-02-20

Date posted

2015-05-28

Date terminated

2015-12-08

Location

Sunnyvale, CA

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