BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS ADVANCED FEMTOSECOND LASER

    MDR report key: 1971702 · Received January 20, 2011

    Report

    Report Number
    MW5019120
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    June 20, 2008
    Report Date
    January 20, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD IFS LASIK SURGERY ON BOTH EYES IN (B)(6) 2008. IN (B)(6) 2010, I DEVELOPED A CATARACT IN MY RIGHT EYE THAT CREATES SIGNIFICANT CLOUDINESS AND GLARE - PARTICULARLY AT NIGHT. NO ONE IN MY FAMILY HAS DEVELOPED CATARACTS PRIOR TO THEIR EARLY 70S, I AM (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IFS ADVANCED FEMTOSECOND LASER LASIK SURGERY DEVICE GEX ABBOTT MEDICAL OPTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability