BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE DOUBLE MOIST

    MDR report key: 2820540 · Received April 30, 2012

    Report

    Report Number
    3004178847-2012-00002
    Event Type
    Injury
    Date Received
    April 30, 2012
    Report Date
    January 30, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS INC.
    Product Code
    LPN
    PMA / PMN Number
    K030092
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR OF THE REPORTED DEVICE PERFORMED CHEMISTRY EVALUATIONS OF PRODUCT RETAINED FROM LOT# ZJ02168; ALL RESULTS WERE WITHIN PRODUCT SPECIFICATIONS. BATCH RECORD REVIEW FOR COMPLETE DOUBLE MOIST LOT# ZJ02168; ALL RESULTS WERE WITHIN PRODUCT SPECIFICATIONS. BATCH RECORD REVIEW FOR COMPLETE DOUBLE MOIST LOT ZJ02168 AND CHEMISTRY AND MICROBIOLOGICAL ANALYSIS OF A RETAINED UNIT OF THE SAME LOT ARE ONGOING. ALL PERTINENT INFO AVAILABLE TO AMO HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    OUR OFFICE IN JAPAN RECEIVED A TELEPHONE CALL FROM A FEMALE PT REPORTING THAT SHE EXPERIENCED CONJUNCTIVITIS, HYPEREMIA, AND A CORNEAL SCAR AFTER USING COMPLETE DOUBLE MOIST. THE PT REPORTED THAT SHE WAS PRESCRIBED AN OCULAR ANTIBIOTIC: CRAVIT OPHTHALMIC SOLUTION 0.5% (LEVOFLOXACIN HYDRATE), USED IT FOR 7 DAYS, AND HER SYMPTOMS RESOLVED. IT IS UNK IF THE REPORTED CORNEAL SCAR HAS BEEN AFFECTED HER VISUAL ACUITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE DOUBLE MOIST LPN ABBOTT MEDICAL OPTICS INC. ZJ02168

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention