BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE MOISTUREPLUS

    MDR report key: 861000 · Received June 5, 2007

    Report

    Report Number
    2020664-2007-00044
    Event Type
    Injury
    Date Received
    June 5, 2007
    Report Date
    May 16, 2007
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC.
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    IN 2007, AMO INITIATED AN IMMEDIATE AND VOLUNTARY RECALL OF ITS COMPLETE MOISTUREPLUS CONTACT LENS SOLUTION IN RESPONSE TO INFO PROVIDED THAT DAY BY U.S. CENTERS FOR DISEASE CONTROL AND PREVENTION REGARDING EYE INFECTIONS FROM ACANTHAMOEBA. THEREFORE, THIS EVENT IS BEING REPORTED AS A 5-DAY MDR.

    Description of Event or Problem · 1

    AMO RECEIVED A REPORT OF A PT CURRENTLY UNDERGOING TREATMENT FOR AN ACANTHAMOEBA INFECTION. REPORTEDLY THE DRS BELIEVE THE INFECTION IS THE RESULT OF THE PT WEARING HIS CONTACT LENSES WHILE SURFING. THE PT WAS USING COMPLETE MOISTURE PLUS AS PART OF HIS CONTACT LENS CARE REGIMEN AT THE TIME OF THE INCIDENT. DATE OF EVENT IS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other