BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE MULTIPURPOSE SOLUTION

    MDR report key: 1523825 · Received October 28, 2009

    Report

    Report Number
    2020664-2009-00063
    Event Type
    Malfunction
    Date Received
    October 28, 2009
    Report Date
    September 29, 2009
    Manufacturer
    ABBOTT MEDICAL OPTICS, INC.
    Product Code
    LPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CHEMISTRY EVAL RESULTS OF COMPLAINT UNIT WERE WITHIN SPECS. MICROBIOLOGY EVAL OF COMPLAINT UNIT SHOWED THE SOLUTION TO BE NO LONGER STERILE. MICROBIOLOGY EVAL OF RETAINED UNIT FROM THE REPORTED LOT SHOWED THE SOLUTION TO BE STERILE. THE ROOT CAUSE HAS NOT BEEN IDENTIFIED.

    Description of Event or Problem · 1

    OUR OFFICE IN (B) (4) INDICATED A MALE PT EXPERIENCED A RED AND UNCOMFORTABLE EYE WHILE USING COMPLETE MULTIPURPOSE SOLUTION TO CARE FOR CONTACT LENSES. THERE WAS NO INDICATION THAT THE PT SOUGHT MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE MULTIPURPOSE SOLUTION LPN ABBOTT MEDICAL OPTICS, INC. NA ZD03250

    Patients

    Seq Age Sex Outcome Treatment
    1