BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MT-4 LENS

    MDR report key: 130174 · Received October 30, 1997

    Report

    Report Number
    MW1012411
    Event Type
    Injury
    Date Received
    October 30, 1997
    Date of Event
    October 16, 1984
    Report Date
    October 30, 1997
    Manufacturer
    ALCON SURGICAL CILCO
    Product Code
    HQL
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR STATES NEVER TOLD RPTR THAT THE MT4 LENS IMPLANT WAS PART OF A "PEOPLE STUDY" RPTRS LAST DAY OF EMPLOYMENT, OCT. 14, 1984. RPTR'S SURGERY OCT. 16, 1984. DOC. NEVER TOLD RPTR THAT THIS MT4 LENS IMPLANT WOULD CAUSE INJURY OR LOSS OF EYE SIGHT. RPTR WAS TOLD BY DOC. AND HIS STAFF AFTER TWO WEEKS, RPTR WOULD BE ABLE TO SEE. DUE TO THE MT4 LENS IMPLANTS RPTR NEVER COULD SEE THREW THE LENS. IN OTHER WORDS THIS IS A LIFE TIME INJURY WITHOUT VISION. RPTR'S EMPLOYMENT INSURANCE PAID FOR HOSP, SURGERY, AND DOC. NOTHING WAS FREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MT-4 LENS Implant MT-4 LENS IMPLANTS HQL ALCON SURGICAL CILCO MT4 A4340B

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| S