BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLEAR COMPATIBLES

    MDR report key: 751601 · Received September 4, 2005

    Report

    Report Number
    MW1036542
    Event Type
    Injury
    Date Received
    September 4, 2005
    Date of Event
    September 4, 2005
    Report Date
    September 4, 2005
    Manufacturer
    COOPERVISION
    Product Code
    LPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FOR THE SECOND TIME IN ABOUT A YEAR, FROM 2 DIFFERENT VENDORS, I HAVE HAD STERILITY PROBLEMS WITH COOPERVISION PROCLEAR COMPATIBLES CONTACT LENSES. THE FIRST INCIDENT WAS FROM BOXES OF WHAT TURNED OUT TO BE COUNTERFEIT LENSES OBTAINED THROUGH PHONE SUPPLIERS AND RESULTED IN A PRODUCT RECALL. APPROXIMATELY 5% OF PHONE SUPPLIER INVENTORY WAS DETERMINED TO BE COUNTERFET. I AM NOW USING MY HEALTH CARE PROVIDER, AND NOW HAVE ANOTHER LOT WITH VISIBLE CONTAMINANTS. CURRENT LOT: 200481459G EXP:2009/06. MANUFACTURER: COOPERVISION. OTHER: PROCLEAR COMPATIBLES BC: 8.6 DIA: 14.2 PWR: -3.25.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCLEAR COMPATIBLES CONTACT LENS LPL COOPERVISION * 200481459G

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other| R