BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE MOISTUREPLUS MULTI-PURPOSE

    MDR report key: 843640 · Received April 27, 2007

    Report

    Report Number
    2020664-2007-00019
    Event Type
    Injury
    Date Received
    April 27, 2007
    Report Date
    January 26, 2007
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC.
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW OF THE REPORTED LOT AND CHEMISTRY TESTING ON A RETAINED UNIT WERE PERFORMED; ALL RESULTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED THAT A FEMALE PT EXPERIENCED KERATITIS FOLLOWING USE OF COMPLETE MOISTUREPLUS MULTI-PURPOSE SOLUTION. SHE INITIALLY SOUGHT TREATMENT FROM A FAMILY DOCTOR WHO PRESCRIBED ANTIBIOTIC EYE DROPS. SYMPTOMS ABATED BUT RESUMED UPON LENS WEAR. WEEKS LATER, THE PT CONSULTED THE OPTOMETRIST WHO NOTED INFILTRATES AND CLOUDY CORNEA OU. HE PRESCRIBED DIFFERENT ANTIBIOTIC EYE DROPS. STATUS OF PATIENT RECOVERY IS UNKNOWN. NO FURTHER INFO WAS REC'D FROM THE OPTOMETRIST DESPITE 3 FOLLOW-UP ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE MOISTUREPLUS MULTI-PURPOSE LPN LPN ADVANCED MEDICAL OPTICS, INC. NA AB03403

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other