BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE MOISTUREPLUS

    MDR report key: 883785 · Received July 20, 2007

    Report

    Report Number
    2020664-2007-00102
    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

    BATCH DOCUMENTATION REVIEW REQUESTED; RESULTS PENDING. AMO INITIATED AN IMMEDIATE AND VOLUNTARY RECALL OF ITS COMPLETE MOISTUREPLUS CONTACT LENS SOLUTION IN RESPONSE TO INFORMATION PROVIDED THAT DAY BY THE CENTERS FOR DISEASE CONTROL AND PREVENTION REGARDING EYE INFECTIONS FROM ACANTHAMOEBA. THEREFORE, THIS EVENT IS BEING REPORTED AS A MDR. THE RELATIONSHIP, IF ANY, OF THE DEVICE TO THE REPORTED INCIDENT / ADVERSE EVENT IS UNKNOWN. THE COMPLAINANT IMPLIED AN ASSOCIATION BETWEEN THE AMO DEVICE AND THE REPORTED EVENT. ROOT CAUSE HAS NOT BEEN ESTABLISHED.

    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 AB00064. WE ARE ATTEMPTING TO OBTAIN FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE MOISTUREPLUS LPN ADVANCED MEDICAL OPTICS, INC. NA AB00064

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other SOFT CONTACT LENSES