BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRK LASER MACHINE

    MDR report key: 12689348 · Received October 22, 2021

    Report

    Report Number
    MW5104923
    Event Type
    Injury
    Date Received
    October 22, 2021
    Date of Event
    July 1, 2021
    Report Date
    October 21, 2021
    Product Code
    OTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD PRK LASIK SURGERY DONE AND IT HAS RUINED MY EYES. SEVERE COMPLICATIONS. THIS EFFECTS MY ABILITY TO WORK AND DO NORMAL DAY TO DAY ACTIVITIES. I HAVE A SEVERE CASE OF PHOTOPHOBIA FOLLOWED BY OCULAR PAIN. CHRONIC DRY EYES. (B)(6) EYE CENTER. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1576396 PRK LASER MACHINE FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION OTL

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Disability