BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK EYE (LASER) MACHINE

    MDR report key: 11998616 · Received June 15, 2021

    Report

    Report Number
    MW5101867
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    March 8, 2018
    Report Date
    June 10, 2021
    Manufacturer
    UNK
    Product Code
    LZS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD LASIK EYE SURGERY AT (B)(6) AND MY VISION IS NOW WORSE THAN BEFORE HAVING THE PROCEDURE. I WAS IN GLASSES ALMOST IMMEDIATELY AFTER SURGERY. I WAS SUICIDAL AND NOW DEAL WITH DEPRESSION AND PTSD FROM THE PROCEDURE. THEY WERE DISHONEST ABOUT WHAT THEY WERE GOING TO DO AND DENY IT NOW. THEY PERFORMED MONOVISION WITHOUT TELLING ME THAT'S WHAT IT WAS AND FULLY DISCLOSING INFORMATION. I WOULD NOT HAVE APPROVED IF THEY HAD BEEN TRUTHFUL. I HAVE BLURRED VISION, DAILY MIGRAINES, TROUBLE WALKING AND WITH DEPTH PERCEPTION, SENSITIVITY TO LIGHT, INABILITY TO FOCUS, CANNOT DRIVE AT NIGHT, HAVE STARBURSTS, HALOS, HOAS AND SEVERE DRY EYE AND EYE PAIN. (B)(6). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894922 LASIK EYE (LASER) MACHINE EXCIMER LASER SYSTEM LZS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention| S DRY EYE DROPS| HOT AND COLD COMPRESSES| IBUPROFIN| REWETTING DROPS| SINUS RINSES| VIAMIN C AND D