BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK

    MDR report key: 1132777 · Received August 21, 2008

    Report

    Report Number
    MW5008056
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    October 12, 2005
    Report Date
    August 21, 2008
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    I AM BLIND AS A RESULT OF THIS PROCEDURE. I HAVE NO PERIPHERAL VISION AND THERE IS AN AURA OR SOME KINK OF COLORED LIGHT AROUND EVERY OBJECT THAT I AM ABLE TO SEE. MY EYES ARE EXTREMELY DRY AND SWOLLEN. MY VISION WILL NEVER BE RESTORED. THIS IS HORRIBLE. DIAGNOSIS OR REASON FOR USE: VISION RESTORATION. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASIK LASIK LASER LZS

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Congenital Anomaly| H| O| R