BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE LASER WITH VISEX TRACKING

    MDR report key: 2013465 · Received March 4, 2011

    Report

    Report Number
    MW5019690
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    September 27, 2007
    Report Date
    March 4, 2011
    Manufacturer
    INTRA LASE CORP.
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY 4-6 MONTHS AFTER I HAD LASIK SURGERY I DEVELOPED SEVERE DRY EYE, STARBURST VISION -MORE SEVERE AT NIGHT-, AND DECREASED VISION CLARITY. THE DRY EYE AND DECREASED VISION CLARITY IS INTERMITTENT, BUT THE STARBURST IS CONSTANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE LASER WITH VISEX TRACKING INTRALASE LZS INTRA LASE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention