BEUDAMED
    FDA Recall Terminated

    Glaucoma Aqueous Shunt 365 mm, valved, P/N EG365V

    Recall: Z-0846-06 · Initiated April 12, 2006

    Recall

    Recall Number
    Z-0846-06
    Event Number
    35214
    Firm
    Eagle Vision Inc
    FEI Number
    1000022662
    Product Code
    KYF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 12, 2006
    Posted
    May 6, 2006
    Terminated
    September 13, 2006
    Address
    8500 Wolf Lake Dr, Ste 110, Memphis, TN, 38133-4104

    Description

    Glaucoma Aqueous Shunt 365 mm, valved, P/N EG365V

    Reason

    Product may have deformed valves which would cause the valve not to operate properly.

    Action

    Written notification of the recall was sent out beginning 04/12/2006 to hospital administrators to advise them of the recall. The letter stated that implanting physicians were to be notified. A second updated notice was sent dated 04/19/2006 which contained more detailed information regarding the product problem.

    Distribution

    Nationwide, Canada, Columbia, Turkey, & The Netherlands

    Quantity

    22 units