BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE MOISTUREPLUS

    MDR report key: 883786 · Received July 20, 2007

    Report

    Report Number
    2020664-2007-00103
    Event Type
    Injury
    Date Received
    July 20, 2007
    Report Date
    June 25, 2007
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC.
    Product Code
    LPN
    Removal / Correction Number
    PENDING
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US

    Narratives

    Additional Manufacturer Narrative · 1

    CHEMISTRY FOR RETAINED SAMPLE AND BATCH RECORD REVIEW PREVIOUSLY REQUESTED FROM MFG SITE. RESULTS WERE WITHIN PRODUCT SPECIFICATIONS AND BATCH RECORD REVIEW UNREMARKABLE. AMO INITIATED AN IMMEDIATE AND VOLUNTARY RECALL OF ITS COMPLETE MOISTUREPLUS CONTACT LENS SOLUTION IN RESPONSE TO INFORMATION PROVIDED THAT DAY BY THE US CENTERS FOR DISEASE CONTROL AND PREVENTION REGARDING EYE INFECTIONS FROM ACANTHAMOEBA.

    Description of Event or Problem · 1

    THE CENTERS FOR DISEASE CONTROL AND PREVENTION MADE DATA AVAILABLE TO AMO SHOWING THAT IT HAD INTERVIEWED AN ADDITIONAL 24 PATIENTS WHO HAD BEEN DIAGNOSED WITH ACANTHAMOEBA INFECTIONS SINCE 2005. FURTHER DETAILS PROVIDED BY THE CDC INDICATED THAT ONE PATIENT USED LOT AA00984. WE ARE ATTEMPTING TO OBTAIN FURTHER INFORMATION. ROOT CAUSE HAS NOT BEEN ESTABLISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE MOISTUREPLUS LPN ADVANCED MEDICAL OPTICS, INC. NA AA00984

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other