BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE MULTI-PURPOSE EASY RUB FORMULA

    MDR report key: 1672874 · Received April 29, 2010

    Report

    Report Number
    2020664-2010-00011
    Event Type
    Malfunction
    Date Received
    April 29, 2010
    Date of Event
    November 25, 2009
    Report Date
    November 25, 2009
    Manufacturer
    ABBOTT MEDICAL OPTICS, INC.
    Product Code
    LPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS FOR THE REPORTED LOT (AD00696) WAS PERFORMED; NO DEVIATIONS WERE NOTED AND PRODUCT MET ALL SPECS. CHEMISTRY EVAL RESULTS OF THE COMPLAINT UNIT AND A RETAINED UNIT FROM THE REPORTED LOT WERE WITHIN SPECS. MICROBIOLOGY EVAL OF A RETAINED UNIT FROM THE REPORTED LOT SHOWED THE SOLUTION TO BE STERILE. THE COMPLAINT UNIT WAS RETURNED FOR MICROBIOLOGY TESTING. BUT AS THE COMPLAINT UNIT WAS ALREADY OPENED, MICROBIOLOGY RESULTS SHOW THAT THE SAMPLE WAS NOT STERILE. USER ERROR MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    OUR OFFICE IN (B) (4) REC'D A REPORT FROM THE MOTHER OF A MALE PT THAT HER SON EXPERIENCED AN "INFECTION" AFTER USE OF COMPLETE MULTI-PURPOSE SOLUTION EASY RUB FORMULA (SEE RELATED COMPLAINT, MDR #2020664-2009-00088). THERE IS NO INDICATION THAT HE REC'D ANY MEDICAL ATTENTION, AND HIS SYMPTOMS HAVE RESOLVED. SHE DESCRIBED HIS LENS CARE REGIMEN AS ALWAYS USING FRESH SOLUTION AND RINSING HIS LENS CASE WITH COMPLETE MPS. HE DID NOT RUB HIS CONTACTS BUT SHE REPORTED THAT HE WOULD SHAKE THE LENS CASE INSTEAD. PRIOR TO THE INFECTION, THE PT WAS USING MONTHLY DISPOSABLE CONTACT LENSES; HE IS NOW USING DAILY DISPOSABLE CONTACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE MULTI-PURPOSE EASY RUB FORMULA LPN ABBOTT MEDICAL OPTICS, INC. NA AD00696

    Patients

    Seq Age Sex Outcome Treatment
    1