BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK

    MDR report key: 6131576 · Received November 25, 2016

    Report

    Report Number
    MW5066374
    Event Type
    Injury
    Date Received
    November 25, 2016
    Date of Event
    June 12, 2015
    Report Date
    November 25, 2016
    Manufacturer
    UNK
    Product Code
    OOE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD LASIK SURGERY IN (B)(6) 2015 AFTER I HAD MY POSTOP VISIT THEY STARTED TO SEE ME FREQUENTLY FOR MY DRY EYES AND VISION PROBLEMS. I WAS GETTING NO HELP FROM THE SURGEON OR THE CLINIC AT THE TIME SO I WENT TO MY REGULAR HEALTH PROVIDER TO SEEK FOR HELP. I DID A COMPLAINT TO THE MEDICAL BOARD OF THE SURGEON THAT OPERATED IN MY EYE. AFTER A LOT OF FOLLOW UP APPOINTMENTS WITH MY PROVIDER THEY FINALLY REACHED OUT TO ME TO SEE WHAT WAS GOING ON. I'LL EXPLAIN, AFTER SURGERY I STARTED TO DEVELOP DRY EYE SYNDROME AND FLASHES OF LIGHT WITH FLOATERS. IT'S BEEN ONE YEAR AND A HALF THAT I STILL HAVE THESE PROBLEMS WITH MY EYES. MY FLOATERS ARE INCREASING AND MY HEALTH PROVIDER IS WORRIED I MIGHT HAVE A RETINA DETACHMENT. SO I'M FREQUENTLY DO YOU FOLLOW UP WITH IT WHICH EVERY SIX MONTHS THEY DILATE MY EYES TO SEE BENEATH MY EYES, WHAT THE PROBLEM IS HERE IS THAT I MIGHT LOSE MY VISION PERMANENTLY. BEFORE MY SURGERY MY EYES WERE FINE BESIDES MY VISION. ALL THE DOCTOR SAID MY EYES WERE GOOD. I JUST NEEDED GLASSES TO SEE BETTER FROM FAR AWAY. AFTER LASIK SURGERY MY EYE STARTED TO DEVELOP THINGS I NEVER HAD BEFORE THAT WILL BE DRY EYES, FLASHES OF LIGHT, AND FLOATERS AND HAVING PERMANENT PLUGS IN MY EYES TO KEEP MY EYES MOIST. I HAVE TO USE ARTIFICIAL TEARS EVERY HOUR OF MY LIFE WHEN I'M AWAKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778202 LASIK LASIK OOE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Disability