BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SVS APEX PLUS EXCIMER LASER WORKSTATION

    MDR report key: 262203 · Received February 7, 2000

    Report

    Report Number
    1287364-2000-00001
    Event Type
    Malfunction
    Date Received
    February 7, 2000
    Date of Event
    December 16, 1999
    Report Date
    January 28, 2000
    Manufacturer
    SUMMIT TECHNOLOGY, INC.
    Product Code
    LZS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 1999, THE COMPLAINANT REPORTEDLY PERFORMED A BILATERAL LASIK PROCEDURE ON A MYOPIC WITH ASTIGMATISM PT. NO COMPLICATIONS WERE REPORTED IN THE TREATMENT OF THE FIRST EYE. IN TREATING THE SECOND EYE OF THIS PT, THE OUTCOME RESULTED IN A HYPEROPIC CONDITION WITH ASTIGMATISM. THE COMPLAINANT ALLEGES THAT A MISSING "O" RING ON THE EMPHASIS CASSETTE COMPONENT OF THE LASER SYSTEM CONTRIBUTED TO THE HYPEROPIC ASTIGMATISM IN THE SECOND EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SVS APEX PLUS EXCIMER LASER WORKSTATION EXCIMER LASER SYSTEM LZS SUMMIT TECHNOLOGY, INC. UV325000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other