BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 105949 · Received July 16, 1997

    Report

    Report Number
    MW1011710
    Event Type
    Injury
    Date Received
    July 16, 1997
    Date of Event
    September 1, 1996
    Report Date
    July 16, 1997
    Manufacturer
    SUMMIT TECHNOLOGY, INC.
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD A TOTAL OF 5 SURGERIES TO REPAIR VISION, WHICH BEFORE SURGERY WAS ONLY PARTIALLY CORRECTED BY GLASSES. RPTR NOW HAS SEVERELY BLURRED VISION AT MIDDLE DISTANCES, AND HER NEAR AND DISTANCE VISION HAS WORSENED. RPTR NOW HAS TO USE A MAGNIFYING GLASS IN ADDITION TO HER GLASSES, JUST TO READ AND CAN NO LONGER USE A COMPUTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK EXCIMER LASER LZS SUMMIT TECHNOLOGY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR