BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMO COMPLETE MOISTURE PLUS

    MDR report key: 859398 · Received May 29, 2007

    Report

    Report Number
    MW5002170
    Event Type
    Injury
    Date Received
    May 29, 2007
    Date of Event
    November 1, 2006
    Report Date
    May 29, 2007
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC
    Product Code
    LPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    DEVELOPED EYE INFECTION/PAIN AS RESULT OF USING AMO COMPLETE MOISTURE PLUS BY ADVANCED MEDICAL OPTICS, INC. - WAS NOT AWARE OF REASON AT THE TIME. DOCTOR ADVISED ME TO DISCONTINUE USE OF SOLUTION AND RECOMMENDED FOLLOW-UP VISITS TO INSURE THAT SYMPTOMS WERE NOT THE RESULT OF AN EYE DISEASE. TESTS WERE RUN AND EYE DISEASE WAS RULED OUT. CONTINUE TO HAVE IRRITATION AND PAIN IN EYES. DOSE: DAILY USE TO RINSE. FREQUENCY: 10 SECONDS DAILY. ROUTE: OPHTHALMIC. DATES OF USE: FIVE MONTHS BETWEEN 2006 AND 2007. DIAGNOSIS: CLEAN, RINSE, STORE AND DISINFECT CONTACT LENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMO COMPLETE MOISTURE PLUS NONE LPN ADVANCED MEDICAL OPTICS, INC ZBO2725

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other| S