BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 3022857 · Received March 15, 2013

    Report

    Report Number
    3022857
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ALCON LABORTORIES, INC.
    Product Code
    KYF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    THE MALFUNCTIONING INSERTER WAS EXAMINED BY THE MD AND REPLACED WITH ANOTHER SHUNT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110592 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF ALCON LABORTORIES, INC. P50 121209

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR