BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT

    MDR report key: 285464 · Received July 8, 2000

    Report

    Report Number
    MW1019267
    Event Type
    Injury
    Date Received
    July 8, 2000
    Date of Event
    December 7, 1998
    Report Date
    July 8, 2000
    Manufacturer
    SUMMIT TECHNOLOGY, INC.
    Product Code
    HQF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DURING LASIK EYE SURGERY, THE LASIK MACHINE WHICH IS MANUFACTURED BY SUMMIT DID NOT SHUT OFF WHEN THE PROGRAMMED NUMBER OF PULSES WERE DELIVERED. SINCE THIS PROCEDURE IS STILL BEING STUDIED, RPTR ASSUMES THAT THE DR REPORTED THIS TO FDA. RPTR'S LEFT EYE WAS DAMAGED AND VISION IS IMPAIRED. SUMMIT CORP HAS NOT CONTACTED RPTR WITH A SOLUTION AND DID NOT EVEN ANSWER A LETTER SENT TO THEM BY THEIR LAWYER OVER A YEAR AGO. THE SURGERY WAS PERFORMED AT HOSP. NOTHING, SO FAR, HAS BEEN OFFERED OR DONE TO CORRECT EYE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT LASIK LAZER MACHINE HQF SUMMIT TECHNOLOGY, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Disability