BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE MOISTUREPLUS

    MDR report key: 870935 · Received June 25, 2007

    Report

    Report Number
    2020664-2007-00061
    Event Type
    Injury
    Date Received
    June 25, 2007
    Report Date
    May 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

    USED FOR BATCH RECORD REVIEW REQUESTED FROM MANUFACTURING SITE; RESULTS PENDINGS. FDA ANTIMICROBIAL EFFECTIVENESS PANEL DOES NOT REQUIRE THE DEVICE TO KILL THE ORGANISM. IN 2007, AMO INITIATED AN IMMEDIATE AND VOLUNTARY RECALL OF ITS COMPLETE MOISTUREPLUS CONTACT LENS SOLUTION IN RESPONSE TO INFO PROVIDED THAT DAY BY THE US CENTERS FOR DISEASE CONTROL AND PREVENTION REGARDING EYE INFECTIONS FROM ACANTHAMOEBA.

    Description of Event or Problem · 1

    THE US CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) MADE DATA AVAILABLE TO AMO SHOWING THAT IT HAD INTERVIEWED 46 PTS WHO HAD DEVELOPED ACANTHAMOEBA KERATITIS INFECTIONS REPORTED SINCE 2005. A TOTAL 39 PTS WERE SOFT CONTACT LENS WEARERS, 21 OF WHOM REPORTED USING COMPLETE MOISTUREPLUS. ADD'L INFO PROVIDED BY THE CDC INDICATED THAT ONE PT HAD USED LOT AB01434, EXP. 05/2008. WE ARE ATTEMPTING TO OBTAIN FURTHER INFO. 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 AB01434

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other