BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE MOISTURE PLUS

    MDR report key: 988471 · Received January 24, 2008

    Report

    Report Number
    MW5005094
    Event Type
    Malfunction
    Date Received
    January 24, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 24, 2008
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC
    Product Code
    LPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    UPON USING AMO COMPLETE MOISTURE PLUS CONTACT LENS SOLUTION OVER THE COURSE OF ABOUT 3 WEEKS, I HAVE SUFFERED FROM IRRITATED, ITCHY, AND RED EYES. THE CONDITION SUBSIDES ONCE THE CONTACT LENSES WHICH HAVE BEEN STORED IN THE SOLUTION, ARE REMOVED FROM MY EYES. I AM AWARE THAT THE PRODUCT WAS RECALLED NOVEMBER OF 2006 AND INADVERTENTLY USED THIS BOTTLE RECENTLY. I HAVE CONTACTED AMO ADVANCED MEDICAL OPTICS, INC WHO CLAIM NO RESPONSIBILITY FOR MY REACTION. I WAS TOLD THAT A MEDICAL TEAM MIGHT BE IN TOUCH WITH ME AND THAT THEY MIGHT WANT TO TEST THE SOLUTION. THEY CONTEND THAT THERE IS NO PROOF OF CONTAMINATION. I HAVE WORN CONTACT LENSES FOR 24 YRS AND HAVE EVER HAD ANY KIND OF REACTION LIKE THIS. DOSE OR AMOUNT: ENOUGH SOLUTION TO FILL LENS, FREQUENCY: NIGHTLY. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: TO CLEAN AND STORE MY SOFT CONTACT LENSES. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES. EVENT REAPPEARED AFTER REINTRODUCTION? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE MOISTURE PLUS NONE LPN ADVANCED MEDICAL OPTICS, INC ZB03358

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other