BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCED MEDICAL OPTICS INC

    MDR report key: 1025014 · Received April 2, 2008

    Report

    Report Number
    MW5006114
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    March 31, 2008
    Report Date
    April 2, 2008
    Manufacturer
    ADVANCED MEDICAL OPTICS INC
    Product Code
    LPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS USING AMO COMPLETE MOISTURE PLUS WITH HER CONTACTS; EYES BECAME RED, SWOLLEN AND SENSITIVE TO LIGHT. PRODUCT IS ON RECALL LIST. DOSE OR AMOUNT: QS FOR IRRIGATION OR SOAKING. FREQUENCY: DAILY. ROUTE: OTIC. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: FOR CLEANING CONTACT LENSES. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCED MEDICAL OPTICS INC AMO COMPLETE MOISTURE PLUS LPN ADVANCED MEDICAL OPTICS INC ABO4228

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other