BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUSTOM-MADE ARTIFICIAL EYE

    MDR report key: 31833 · Received April 5, 1996

    Report

    Report Number
    MW1008821
    Event Type
    Other
    Date Received
    April 5, 1996
    Date of Event
    November 26, 1986
    Report Date
    March 28, 1996
    Manufacturer
    FREDRICK LEWIS
    Product Code
    HPZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR FOUND THIS FORM IN HIS PUBLIC CITIZEN HEALTH LETTER. THIS OCULAR PROSTHESIS WAS TO HAVE BEEN FOR REPLACEMENT FOR LENGTHY USE. LESS THAN 3 WEEKS OF IMPLANTATION USE. HE SUFFERED SEVERE CHEMICAL BURNS TO HIS EYE SOCKET CAUSED BY THE NEWLY MADE ARTIFICIAL EYE, THAT PERSISTS TO THIS DAY. HE FEELS PRICE GOUGING IN THIS TRADE IS VERY COMMON, AND QUALITY CONTROL AND GOVERNMENT REGULATION NONEXISTENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM-MADE ARTIFICIAL EYE Implant ARTIFICIAL EYE HPZ FREDRICK LEWIS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other