BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIVATE LABEL MULTIPURPOSE SOLUTION

    MDR report key: 3035059 · Received January 30, 2013

    Report

    Report Number
    3004537773-2013-00001
    Event Type
    Other
    Date Received
    January 30, 2013
    Date of Event
    August 3, 2012
    Report Date
    October 8, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS INC.
    Product Code
    LPN
    PMA / PMN Number
    K014202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE REPORTED LOT WAS PERFORMED; NO DEVIATIONS WERE NOTED AND PRODUCT MET ALL SPECIFICATIONS. CHEMISTRY EVALUATION RESULTS OF RETAINED UNIT FROM THE REPORTED LOT WERE WITHIN SPECIFICATIONS. MICROBIOLOGY EVALUATION OF RETAINED UNIT FROM THE REPORTED LOT SHOWED THE SOLUTION TO BE STERILE. THE ROOT CAUSE HAS NOT BEEN ESTABLISHED. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A REVIEW OF THE FDA (B)(4) DATA BASE ((B)(4)) REVEALED A REPORT FROM A MALE CONSUMER WHO REPORTED HE EXPERIENCED BILATERAL CORNEAL ULCERS WHILE USING PRIVATE LABEL MULTIPURPOSE SOLUTION. THE PATIENT DID NOT RESPOND TO MULTIPLE ATTEMPTS TO GATHER FOLLOW UP INFORMATION OR RETURN THE BOTTLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41979 PRIVATE LABEL MULTIPURPOSE SOLUTION LPN ABBOTT MEDICAL OPTICS INC. AK00445

    Patients

    Seq Age Sex Outcome Treatment
    1 Other