BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSEPT 1 STEP NEUTRALIZING TABLET

    MDR report key: 1220373 · Received October 31, 2008

    Report

    Report Number
    2020664-2008-00051
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    July 16, 2008
    Report Date
    August 5, 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: CHEMISTRY TESTS FOR RETAIN SAMPLE ARE WITHIN SPECIFICATION. RETURNED ITEM: THE SPECIFICATION TEST WAS PERFORMED USING THE RETURNED SAMPLE. THE RESULT OF CATALASE ACTIVITY WAS OUT OF SPEC. PATIENT RETURNED DISINFECTING AND NEUTRALIZING SOLUTION USED AT THE TIME OF EVENT IN THE SYSTEM LENS CUP. DISINFECTING SOLUTION WAS NOT COMPLETELY NEUTRALIZED.

    Description of Event or Problem · 1

    A MALE PATIENT REPORTED HE HAD EYE PAIN (BURNING) AFTER USING CONCEPT 1 STEP ON HIS LENSES; THE SOLUTION DID NOT TURN PINK OR NEUTRALIZE. PATIENT RECOVERED WITHOUT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSEPT 1 STEP NEUTRALIZING TABLET LPN ADVANCED MEDICAL OPTICS, INC. 17537

    Patients

    Seq Age Sex Outcome Treatment
    1