BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1683-2015 · Initiated February 20, 2015

    Recall

    Recall Number
    Z-1683-2015
    Event Number
    70672
    Firm
    Optimedica Corporation
    FEI Number
    3005675890
    Product Code
    OOE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 20, 2015
    Posted
    May 28, 2015
    Terminated
    December 8, 2015
    Address
    1310 Moffett Park Dr, Sunnyvale, CA, 94089-1133

    Description

    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.

    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.

    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 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.

    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.

    Quantity

    171 distributed Worldwide