BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE MOISTUREPLUS

    MDR report key: 1003454 · Received February 24, 2008

    Report

    Report Number
    MW5005680
    Event Type
    Injury
    Date Received
    February 24, 2008
    Date of Event
    November 15, 2007
    Report Date
    February 24, 2008
    Manufacturer
    AMO ADVANCED MEDICAL OPTICS
    Product Code
    LPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AU
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS A SOFT LENS USER AND I USED ADVANCED MEDICAL OPTICS COMPLETE MOISTURE. IN NOVEMBER, MY EYE STARTED WITH HEAVY INFLAMMATIONS AND IN DECEMBER FINALLY ACANTHAMOEBA KERATITIS WAS DIAGNOSED. AS A CONSEQUENCE OF THIS I HAD A CORNEA TRANSPLANTATION IN 2008. DATES OF USE: 2006 - 2007. DIAGNOSIS OR REASON FOR USE: SOFT CONTACTS LENS MOISTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE MOISTUREPLUS NONE LPN AMO ADVANCED MEDICAL OPTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L| R