BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLUOROCON

    MDR report key: 12404 · Received March 30, 1994

    Report

    Report Number
    MW1001326
    Event Type
    Other
    Date Received
    March 30, 1994
    Report Date
    March 28, 1994
    Manufacturer
    PILKINGTON BARNES HIND, INC.
    Product Code
    HPX
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS LENS WAS NEVER DISPOSED TO THE PT. BASE CURVE VERIFICATION WAS 8/12 INSTEAD OF 8/07, WELL BEYOND ACCEPTED TOLERANCE OF GOOD MFG PRACTICES AND ANSI STANDARDS. THIS WAS SUPPOSED TO HAVE BEEN RE-INSPECTED FOR ACCURACY BEFORE SHIPMENT. CORNEAL HEALTH COULD HAVE BEEN SERIOUSLY COMPROMISED BY THIS POOR QUALITY CONTROL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUOROCON RIGID GAS PERMEABLE CONTACT LENS HPX PILKINGTON BARNES HIND, INC. 8.07/9.5 DIAM ORDER #4898938/001

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other