BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVUS OMNI ARGON LASER

    MDR report key: 681838 · Received March 6, 2006

    Report

    Report Number
    2914019-2006-00057
    Event Type
    Injury
    Date Received
    March 6, 2006
    Date of Event
    November 5, 2002
    Report Date
    March 5, 2006
    Manufacturer
    COHERENT MEDICAL GROUP
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT WENT TO RETINA CLINIC FOR TREATMENT OF INCREASING DISTORTION IN HIS VISION FROM SCARRING THAT RESULTED FROM EARLIER SURGERIES. LASER SURGERY WAS PERFORMED 2002. THE PATIENT ALLEGES THAT WHILE THE DR WAS SETTING UP THE LASER EQUIPMENT, THE LASER UNEXPECTEDLY FIRED. THE PATIENT HEARD A LOUD NOISE AND HAD A BLINDING FLASH IN HIS EYE. SIMULTANEOUSLY A BLACK SPIKE APPEARED IN HIS CENTRAL VISION AND THAT THE LASER BEAM HIT THE PATIENT'S RETINA , SEVERING NERVE FIBERS LEADING TO HIS CENTRAL VISION. THIS RESULTED IN A PERMANENT WEDGE-SHAPED BLIND SPOT IN THE PATIENT'S LEFT EYE EXTENDING TO THE EXACT CENTER OF HIS VISION. PATIENT FEELS THE DR APPARENTLY TREATED A LARGER AREA THAN HE HAD AGREED TO DO BEFORE THE SURGERY. THIS LEFT A LARGE BLIND SPOT IMMEDIATELY BELOW THE PATIENT'S CENTER OF VISION AND PERMANTLEY DISTORTED HIS CENTRAL VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVUS OMNI ARGON LASER OPHTHALMIC LASERS GEX COHERENT MEDICAL GROUP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other