BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE MOISTUREPLUS

    MDR report key: 879693 · Received July 11, 2007

    Report

    Report Number
    2020664-2007-00093
    Event Type
    Injury
    Date Received
    July 11, 2007
    Date of Event
    February 1, 2005
    Report Date
    June 12, 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

    LOT NUMBER OF SOLUTION USED BY PT IS UNKNOWN. THE MFR HAS ATTEMPTED TO CONTACT THE PATIENT 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 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.

    Description of Event or Problem · 1

    OUR OFFICE REPORTED A MALE PT EXPERIENCED BILATERAL ACANTHAMOEBA KERATITIS FOLLOWING THE USE OF COMPLETE MOISTUREPLUS WITH VARIOUS BRANDS OF CONTACT LENSES. THE PT REPORTED THAT IN 2005, HE WAS DIAGNOSED WITH AK. HE INDICATED HE 'INITIALLY LOSS SIGHT IN BOTH EYES', BUT LATER RECOVERED SIGHT IN ONE EYE AFTER BEING TREATED. HE STATED HE HAD "4 OR 5 CORNEA TRANSPLANTS". EVIDENTIALLY, INITIALLY HIS OPHTHALMOLOGIST SAID THAT IT WAS DUE TO HIS CONTACT LENSES. HE USED THE SOFT BI-WEEKLY FROM DIFFERENT MANUFACTURERS, SUCH AS B&L, CIBA AND OTHER ONES. HE USES A COLLYRIUM CALLED VISIODOSE, PURCHASED IN A FOREIGN COUNTRY, CONTAINING CHLORHEXIDINE, 4 TO 5 TIMES A DAY. FOLLOW UP WITH HIS EYECARE PROFESSIONAL CONFIRMED THAT THE PT WAS DIAGNOSED WITH BILATERAL AK. THE DOCTOR INDICATED THAT THE PT WAS COMPLIANT IN MAINTAINING HIS LENSES AND WAS "NEVER IN CONTACT WITH CONTAMINATED WATER", SO HE FOUND NO OTHER EXPLANATION THAN THINKING THE EVENT WAS DUE TO USE OF THE DEVICE. THE LOT NUMBER OF THE PRODUCT BEING USED WAS NOT PROVIDED. 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 YR Other