BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSEPT 1NEUTRALIZING TABLET

    MDR report key: 1220372 · Received October 31, 2008

    Report

    Report Number
    2020664-2008-00052
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    August 18, 2008
    Report Date
    September 23, 2008
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC.
    Product Code
    LPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETAINED ITEM: VISUAL AND CATALASE TEST FOR RETAIN SAMPLE ARE WITHIN SPECIFICATION. RETURNED ITEM: ONE OF THE TABLETS PROVIDED BY THE PATIENT FOR TESTING WAS WITHIN SPECIFICATION (VISUAL AND CATALASE ACTIVITY). TWO TABLETS PROVIDED BY THE PATIENT WERE WITHIN VISUAL SPECIFICATION, AND NOT WITHIN SPECIFICATION FOR CATALASE ACTIVITY. ROOT CAUSE HAS NOT BEEN ESTABLISHED.

    Description of Event or Problem · 1

    OUR INTN'L AFFILIATE RECEIVED A REPORT THAT ON TWO OCCASIONS, A MALE PATIENT EXPERIENCED RED AND PAINFUL EYES AFTER USING CONSEPT 1STEP NEUTRALIZING TABLET. PATIENT RECOVERED WITHOUT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSEPT 1NEUTRALIZING TABLET LPN ADVANCED MEDICAL OPTICS, INC. 17330

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTACT LENSES - BRAND AND MODEL UNKNOWN