BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASIK

    MDR report key: 1951972 · Received January 3, 2011

    Report

    Report Number
    MW5018873
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    June 28, 2007
    Report Date
    January 3, 2011
    Product Code
    LZS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD LASIK SURGERY IN 2007 IN BOTH EYES. LEFT EYE PROBLEMS INCLUDE MASSIVE STARBURSTS AT NIGHT, HALOS, DRY EYE, EYE CALLOUS, CTK, FOLDS, SKIN INGROWTH NEAR FLAP, PTERYGIUM. RIGHT EYE PROBLEMS SEVERE DRY EYE, HALOS, GLARE, MINOR STARBURSTS. LASIK RE DO SURGERIES (B)(6) 2007, (B)(6) 2007 AND (B)(6) 2008.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention