BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE DOUBLE MOIST

    MDR report key: 4375914 · Received April 20, 2012

    Report

    Report Number
    3004178847-2012-00013
    Event Type
    Malfunction
    Date Received
    April 20, 2012
    Date of Event
    April 20, 2012
    Report Date
    April 20, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS INC.
    Product Code
    LPN
    PMA / PMN Number
    K030092
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE REPORTED LAT WAS PERFORMED; NO DEVIATIONS WERE NOTED AND PRODUCT MET ALL SPECIFICATIONS. MICROBIOLOGY EVALUATION OF THE RETAINED UNIT FROM THE REPORTED LOT SHOWED THE SOLUTION TO BE STERILE. PHYSICO-CHEMICAL ANALYSIS RESULTS OF THE RETURNED UNIT ARE CORRECT AND ALL PARAMETERS ARE WITHIN ESTABLISHED ACCEPTANCE CRITERIA. VISUAL INSPECTION PERFORMED ON THE RETURNED SAMPLE. IT MET SPECIFICATION FOR COMPONENTS INTEGRITY AND PRODUCT LEAKAGE. A YELLOW SUBSTANCE WAS NOTED ON THE THREADS OF ONE BOTTLE WHICH WAS NOT WITHIN SPECIFICATION. THE RESIDUE WAS ANALYZED USED SPECTROSCOPY. THE RESIDUE WAS FOUND TO BE DRIED MULTIPURPOSE SOLUTION WITH THE ADDITIONAL PRESENCE OF BIOLOGICAL MATERIAL (PROTEIN). THE COMPLAINT UNIT WAS RETURNED BACK ALREADY OPENED AND MICROBIOLOGY RESULTS SHOW THAT THE SAMPLE WAS NOT STERILE. THE SECOND BOTTLE PACKAGED WITH THE RETURNED UNIT MET MICROBIOLOGICAL, CHEMISTRY AND VISUAL SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    OUR OFFICE IN (B)(4) RECEIVED A REPORT FROM A DISTRIBUTOR THAT A CONSUMER FOUND DIRT AND A SMALL INSECT INSIDE OF A BOTTLE CAP WHEN SHE OPENED THE BOTTLE OF COMPLETE DOUBLE MOIST. THE REPORTER INDICATED THE SAFETY SEAL WAS IN PLACE WHEN THE BOTTLE WAS INITIALLY OPENED. THE BOTTLE WAS PART OF A TWO PACK. THE CONSUMER DID NOT USE THE PRODUCT; NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE DOUBLE MOIST LPN ABBOTT MEDICAL OPTICS INC. ZK00287

    Patients

    Seq Age Sex Outcome Treatment
    1