BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMO PHACOFLEX II

    MDR report key: 121093 · Received September 18, 1997

    Report

    Report Number
    MW1012117
    Event Type
    Malfunction
    Date Received
    September 18, 1997
    Date of Event
    August 28, 1997
    Report Date
    September 10, 1997
    Manufacturer
    ALLERGAN, INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A LENS IMPLANT MFG BY ALLERGAN MEDICAL OPTICS IS CURRENTLY BEING USED FOR CATARACT SURGERY, AS THE LENS IMPLANT, WORKERS FEEL DELIVERY SYSTEM IS NOT SAFE, ADEQUATE, WHEN PLACED IN THE "SHOOTER, THE FOLDING DEVICE, THE LENS FREQUENTLY BREAKS. ALSO, STAFF CONCERNED WITH MICROSCOPIC DAMAGE TO LENS THAT MAY LEAD TO PROBLEMS LATER AFTER LENS PLACED IN EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMO PHACOFLEX II Implant LENS IMPLANT HQL ALLERGAN, INC. SI40NB *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other