BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1515-2015 · Initiated February 20, 2015

    Recall

    Recall Number
    Z-1515-2015
    Event Number
    70679
    Firm
    Abbott Medical Optics, Inc.
    FEI Number
    3006695864
    Product Code
    OOE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 20, 2015
    Posted
    April 23, 2015
    Terminated
    July 9, 2019
    Address
    510 Cottonwood Dr, Milpitas, CA, 95035-7403

    Description

    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.

    Reason

    Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation.

    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.

    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, Peru, Hong Kong, Saudi Arabia, Bangladesh, and Dominican Rep.

    Quantity

    202