BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIVATE LABEL MULTIPURPOSE SOLUTION

    MDR report key: 3871229 · Received April 16, 2014

    Report

    Report Number
    3004537773-2014-00001
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Report Date
    March 7, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS INC.
    Product Code
    LPN
    PMA / PMN Number
    K014202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER OCCUPATION: COMPANY REPRESENTATIVE; ADDITIONAL INFO WAS NOT PROVIDED. A REVIEW OF THE MFG RECORDS FOR THE REPORTED LOT WAS PERFORMED; NO DEVIATIONS WERE NOTED AND PRODUCT MET ALL SPECIFICATIONS. THERE HAVE BEEN NO REPORTS RECEIVED FOR LOT AM01831. ALL PATIENT INFO AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT FROM OUR OFFICE IN (B)(6) THAT A DISTRIBUTOR HAD A ROUTINE RETAIL AUDIT PERFORMED BY A THIRD PARTY. DURING THE AUDIT, A BOTTLE OF PRIVATE LABEL MULTIPURPOSE SOLUTION WAS TESTED BY ANOTHER THIRD PARTY WHO REPORTEDLY FOUND THAT IT WAS NOT STERILE. ADDITIONAL TESTING PERFORMED BY THE THIRD PARTY LAB INCLUDED: APPEARANCE, FRAGRANCE, PH, PERCENT SOLIDS, OSMOLALITY. THESE PARAMETERS WERE FOUND TO BE ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233685 PRIVATE LABEL MULTIPURPOSE SOLUTION CONTACT LENS DISINFECTING SOLUTION LPN ABBOTT MEDICAL OPTICS INC. AM01831

    Patients

    Seq Age Sex Outcome Treatment
    1