BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIVATE LABEL MULTIPURPOSE SOLUTION

    MDR report key: 1592960 · Received January 28, 2010

    Report

    Report Number
    2020664-2009-00080
    Event Type
    Malfunction
    Date Received
    January 28, 2010
    Date of Event
    September 26, 2009
    Report Date
    December 1, 2009
    Manufacturer
    ABBOTT MEDICAL OPTICS, INC.
    Product Code
    LPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 EVAL OF RETAINED UNIT FROM THE REPORTED LOT SHOWED THE SOLUTION TO BE STERILE. MANUFACTURER OF REPORTED DEVICE PERFORMED MICROBIOLOGY AND CHEMISTRY EVALUATIONS OF THE ACTUAL PRODUCT USED BY THE CONSUMER. THE PRODUCT DID NOT MEET CHEMISTRY OR MICROBIOLOGICAL SHELF LIFE SPECIFICATIONS. ADD'L TESTING SHOWED THE COMPLAINT UNIT CONTAINED THE FOLLOWING SUBSTANCES: ACETIC ACID (0.60%), GLUCONIC ACID (0.75%), TARTARIC ACID (0.03%) AND CITRATES (0.15%). THIS GROUP OF SUBSTANCES ARE TYPICALLY FOUND IN SOME TYPES OF VINEGARS. ADD'L TESTING IS STILL IN PROCESS. CHEMISTRY TESTING OF THE UN-OPENED, 3RD 'COMPANION' BOTTLE WAS PERFORMED AND FOUND TO MEET PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    MALE PT REPORTED HE EXPERIENCED A BURNING SENSATION AFTER USING A NEW BOTTLE OF THE PRIVATE LABEL MULTIPURPOSE SOLUTION TO CARE FOR HIS ACUVUE BIFOCAL CONTACT LENSES. HE REMOVED THE LENS FROM HIS EYE AND NOTICED IT HAD A 'SHRIVELED' APPEARANCE AS DID THE LENS REMAINING IN HIS LENS CASE. HE DECIDED THE LENSES WERE OLD AND DISCARDED THEM. HE OPENED A NEW PACKAGE OF LENS AND PREPARED THEM USING THE COMPLAINT BOTTLE, AND THEY TOO SHRIVELED. HIS WIFE NOTICED THE SOLUTION IN THE BOTTLE HAD A VINEGAR ODOR. HE INDICATED THAT HE HAD PURCHASED THIS BOTTLE AS PART OF A '3-PACK'. HE HAD USED THE FIRST BOTTLE WITHOUT ANY TROUBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIVATE LABEL MULTIPURPOSE SOLUTION LPN ABBOTT MEDICAL OPTICS, INC. NA AE00138

    Patients

    Seq Age Sex Outcome Treatment
    1 ATENOLOL| GLIPIZIDE| ACUVUE BIFOCAL CONTACT LENSES| METFORMIN| ACTOS