BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK

    MDR report key: 3963428 · Received July 24, 2014

    Report

    Report Number
    MW5037449
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    January 21, 2014
    Report Date
    July 24, 2014
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A LASIK SURGERY IN (B)(6) 2014 WITH DR. (B)(6) AT (B)(6). MY DAYLIGHT VISION WAS PERFECTLY CORRECTED, HOWEVER, MY NIGHT VISION WAS IMPAIRED EVEN AFTER THE SURGERY. IN A DARKER ENVIRONMENT, I SEE GLARE, HALO, STAR BURST AROUND ILLUMINATED ITEMS. IT GETS PARTICULARLY WORSE WHEN THE RATIO BETWEEN THE LIGHT AND DARK ENVIRONMENT DECREASES. THE GLARE OF HALO IS ASYMMETRICAL, AND FOR ME, THE BOTTOM OF THE ILLUMINATED ITEM USUALLY HAS THE WORST HALO. IN ADDITION, MY EYES GOT DRY AND TIRED MORE EASILY AT ABOVE CONDITION. THIS SEVERELY AFFECTED MY NIGHT DRIVING AND TV OR MOVIE WATCHING AS WELL. THE DOCTOR CHECKED THE TREATMENT ZONE AND MY CORNEA, AND HE SAID EVERYTHING LOOKS NORMAL. HE SAID THIS IS PROBABLY BECAUSE THE LASIK TREATMENT CREATED A FLAT SURFACE ON THE EYE BALL WHICH RESULTED THE GLARE. HE DID NOT HAVE ANY SOLUTION TO SOLVE THIS ISSUE AND HE TOLD ME THIS IS GOING TO BE PERMANENT. WHAT IRRITATED ME IS THAT NO ONE EVER MENTIONED THE CHANCE OF GETTING NIGHT VISION IMPAIRMENT BEFORE THE SURGERY AND I HAVE NO IDEA THAT THIS WOULD HAPPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434978 LASIK LASER OPTHALMIC LZS

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR