BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LADARVISION

    MDR report key: 3820095 · Received May 15, 2014

    Report

    Report Number
    MW5036126
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    September 12, 2013
    Report Date
    May 14, 2014
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), 2013, I RECEIVED BLADELESS LASIK SURGERY BY (B)(6) AT (B)(6). I WAS NOT TOLD THE NEGATIVE RISKS OF LASIK DURING MY CONSULTATION PRIOR TO MY SURGERY. THEY ALSO NEVER CHECKED MY PUPIL SIZE. AFTER MY SURGERY MY AFTERCARE WAS EXPLAINED. THEY TOLD ME I MAY EXPERIENCE HALOS AND GLARE TEMPORALLY. I WENT TO ASK MY POST SURGERY APPOINTMENTS AND WERE TOLD THEY ARE TEMPORARY AND WILL ONLY LAST 2 MONTHS. AT 8 MONTHS, I NOW REALIZE THEY ARE PERMANENT BY GETTING A SECOND OPINION. I CAN NO LONGER SEE AT NIGHT TO DRIVE, IN LOW LIGHT CONDITIONS, I SEE GLARE DURING THE DAY AND ALSO CAN'T SEE STREET SIGNS AS CLEARLY. THEY HAVE RUINED MY EYES AND IF THEY WOULD HAVE TOLD ME THE RISKS I WOULD HAVE NEVER EVER GOTTEN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292420 LADARVISION LADARVISION LZS

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Disability