BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK ALL WAVEFRONT

    MDR report key: 3233918 · Received July 14, 2013

    Report

    Report Number
    MW5030924
    Event Type
    Injury
    Date Received
    July 14, 2013
    Date of Event
    April 15, 2013
    Report Date
    July 14, 2013
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD LASIK REFRACTIVE SURGERY AND 2.5 MONTHS LATER STARTED EXPERIENCING BRIGHT FLASHING LIGHTS IN MY LEFT EYE. I WENT BACK TO THE DOCTOR WHOM PERFORMED MY LASIK PROCEDURE AND WAS TOLD THAT MY SYMPTOMS WERE NOT RELATED TO MY LASER SURGERY. HE REFERRED ME TO A RETINAL SPECIALIST WHOM I SAW THE SAME DAY. THE RETINAL SPECIALIST EXAMINED MY EYE AND FOUND TWO TEARS IN MY RETINA. HE THEN PERFORMED SURGERY THAT DAY. I WAS TOLD THAT THE RETINAL TEARS WERE COMMON WITH PEOPLE LIKE ME WHO WERE NEARSIGHTED. I'M ONLY (B)(6) AND MY NEARSIGHTEDNESS PRIOR TO LASIK WAS NOT ON THE SEVERE SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325366 LASIK ALL WAVEFRONT LASIK LZS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Disability