BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE MOISTUREPLUS

    MDR report key: 883790 · Received July 20, 2007

    Report

    Report Number
    2020664-2007-00107
    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

    LOT NUMBER OF SOLUTION USED BY PATIENT IS UNKNOWN. THE MANUFACTURER HAS NO PATIENT DETAILS TO FURTHER OUR INVESTIGATION OF THE LOT NUMBER AND ADVERSE EVENT DETAILS. IT IS UNKNOWN IF THE DEVICE FAILED TO MEET SPECIFICATIONS AS WE HAVE NOT RECEIVED THE COMPLAINT SAMPLE FOR ANALYSIS NOR HAVE WE RECEIVED AN IDENTIFYING LOT NUMBER TO PERFORM PRODUCT INVESTIGATION. THE DEVICE WAS MOST PROBABLY BEING USED FOR TREATMENT, AS THIS TYPE OF DEVICE IS NOT TYPICALLY USED FOR DIAGNOSIS. THE RELATIONSHIP, IF ANY, OF THE DEVICE TO THE REPORTED INCIDENT/ADVERSE EVENT IS UNKNOWN. THE COMPLAINANT REPORTED AN ASSOCIATION BETWEEN THE AMO DEVICE AND THE REPORTED EVENT. HOWEVER, BECAUSE WE HAVE NOT RECEIVED THE COMPLAINT SAMPLE FOR ANALYSIS, NOR HAVE WE RECEIVED AN IDENTIFYING LOT NUMBER TO GUIDE OUR TESTING, WE HAVE BEEN UNABLE TO DETERMINE THE RELATIONSHIP. ON MAY 25 2007 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.

    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 LOT NUMBER INFORMATION OF SOLUTION USED BY 17 PATIENTS IS UNKNOWN. WE ARE ATTEMPTING TO OBTAIN FURTHER INFORMATION. THE 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other