BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK

    MDR report key: 1134043 · Received August 24, 2008

    Report

    Report Number
    MW5008080
    Event Type
    Injury
    Date Received
    August 24, 2008
    Date of Event
    June 19, 2008
    Report Date
    August 24, 2008
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD BILATERAL LASIK EYE PROCEDURE TO CORRECT DISTANCE VISION. I AWOKE THE NEXT DAY TO FIND THAT I HAD 20/20 DISTANCE VISION, BUT I HAD LOST MY NEAR VISION. THAT WAS NOT THE CASE PRIOR TO SURGERY AND I DO NOT REMEMBER BEING SPECIFICALLY WARNED OF THAT POSSIBILITY. I ALSO DEVELOPED DRY EYE, FLOATERS, HALO & GLARE THAT I WAS TOLD WOULD GO AWAY WITHIN A FEW MONTHS HEALING TIME. THEY DID NOT. I ALSO WAS NOT OFFERED THE OPTION OF ONLY HAVING ONE EYE DONE AT A TIME OR WAS THE OPTION OF MONOVISION CORRECTION OFFERED. I AM AN ULTRASOUND TECHNICIAN BY TRADE AND I DEPEND ON BEING ABLE TO SEE NEAR/COMPUTER AND NOW I AM BURDENED WITH HAVING TO WEAR GLASSES AND HAVING TO PAY OFF A HUGE AMOUNT OF LOAN BECAUSE I DIDN'T WANT TO WEAR GLASSES IN THE FIRST PLACE !! DIAGNOSIS OR REASON FOR USE: IMPROVE DISTANCE VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASIK NONE LZS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other