BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER

    MDR report key: 1031630 · Received April 17, 2008

    Report

    Report Number
    MW5006317
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    December 17, 2007
    Report Date
    April 8, 2008
    Product Code
    HQF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN LATE 2006, I HAD CATARACT SURGERY ON MY RIGHT EYE. IN EARLY 2007, THAT DR RETIRED. WHEN I WENT TO A DIFFERENT DR ON APPROX ELEVEN AND A HALF MONTHS LATER, FOR MY YEARLY CHECK-UP, THIS DR SAID HE NEEDED TO LASER MY RIGHT EYE (YAG). AFTER THE "YAG", MY EYE ACHED FOR 3 MONTHS. THE DROPS HE GAVE ME DID NOT HELP AT ALL. THE EYE HURT SO BAD, IT KEPT ME AWAKE AT NIGHT. I NOW HAVE DRY EYES. ALSO A HAZE THAT CROSSES MY VISION EVERY FEW SECONDS. THE INFECTION IN MY EYE LASTED SO LONG THAT IT SPREAD TO MY EARS. I NOW HAVE TINNITUS. THE HAZE AND TINNITUS ARE PERMANENT. I'M TOLD I WILL HAVE TO LIVE WITH THEM THE REST OF MY LIFE. I HAD NONE OF THIS BEFORE THE LASER (YAG).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER NONE HQF

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability