BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK

    MDR report key: 8861385 · Received August 2, 2019

    Report

    Report Number
    MW5088761
    Event Type
    Injury
    Date Received
    August 2, 2019
    Date of Event
    July 30, 2019
    Report Date
    July 31, 2019
    Manufacturer
    UNKNOWN
    Product Code
    LZS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD LASIK WHEN I WAS IN MY THIRTIES. SUBSEQUENTLY, I DEVELOPED DRY EYES BUT, THE BENEFIT OF THE SURGERY FAR OUTWEIGHED THIS COMPLICATION. NOW, I AM (B)(6) AND HAVE BEEN DIAGNOSED WITH EARLY ONSET CATARACTS AFTER EXPERIENCING WORSENING VISION OVER THE LAST YEAR. THERE IS A LEVEL 1 CATARACT IN MY LEFT EYE AND MY RIGHT EYE IS JUST STARTING TO DEVELOPED TO A CATARACT. I EVENTUALLY WILL HAVE TO HAVE CATARACT SURGERY BUT WILL EXPERIENCE COMPROMISED VISION BEFORE I CAN UNDERGO THIS PROCEDURE. I AM CONCERNED THE EVENTUAL CATARACT SURGERY OUTCOME WILL NOT BE GOOD BECAUSE I HAVE PREVIOUSLY HAD LASIK SURGERY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648134 LASIK EXCIMER LASER SYSTEM LZS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other