BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE MOISTUREPLUS

    MDR report key: 875151 · Received July 3, 2007

    Report

    Report Number
    2020664-2007-00081
    Event Type
    Injury
    Date Received
    July 3, 2007
    Date of Event
    December 1, 2006
    Report Date
    June 10, 2007
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC.
    Product Code
    LPN
    Removal / Correction Number
    PENDING
    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 INFORMATION PROVIDED THAT DAY BY THE US CENTERS FOR DISEASE CONTROL AND PREVENTION REGARDING EYE INFECTIONS FROM ACANTHAMOEBA. THEREFORE, THIS EVENT IS BEING REPORTED AS AN MDR. THE RELATIONSHIP, IF ANY, OF THE DEVICE TO THE REPORTED ADVERSE EVENT IS UNKNOWN. THE COMPLAINANT IMPLIED AN ASSOCIATION BETWEEN THE AMO DEVICE AND THE REPORTED EVENT. ROOT CAUSE HAS NOT BEEN ESTABLISHED. BATCH RECORD REVIEW AND RETAIN SAMPLE TESTING HAS BEEN REQUESTED FROM THE MANUFACTURING SITE. RESULTS PENDING.

    Description of Event or Problem · 1

    AMO RECEIVED A REPORT FROM A CONSUMER STATING THAT IN 2006, AFTER REMOVING A 1 WEEK OLD CONTACT AND USING IT THE DAY AFTER, HE EXPERIENCED "SLIGHT PAIN". HE STOPPED USING CONTACTS, BUT THE INFECTION GOT WORSE. HE WAS TREATED AT THE HOSPITAL UNDER A CORNEAL SPECIALIST. HIS LEFT EYE WAS DIAGNOSED WITH ACANTHAMOEBA KERATITIS (AK). HE WAS PUT ON A HIGH REGIME OF DROPS, INCLUDING PHMB, FOLLOWED BY A CORNEAL GRAFT OPERATION IN 2007. THE REPORTER COMPLETED A QUESTIONNAIRE IN WHICH HE INDICATED THAT HE REPLACES HIS LENS CASE EVERY 2-3 MONTHS AND CLEANS IT BY WIPING DRY WITH TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE MOISTUREPLUS LPN ADVANCED MEDICAL OPTICS, INC. NA AA01764

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| R