BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMO COMPLETE MOISTUREPLUS SOLUTION

    MDR report key: 874352 · Received June 26, 2007

    Report

    Report Number
    MW5002839
    Event Type
    Injury
    Date Received
    June 26, 2007
    Date of Event
    May 25, 2007
    Report Date
    June 26, 2007
    Manufacturer
    ADVANCED MEDICAL OPTICS
    Product Code
    LPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM A PHARMACIST, USER OF CONTACT LENSES AND CASUALLY I BOUGHT ON MAY, THE SOLUTION FROM AMO IN CHILE, I BEGAN WITH GREAT TEARING AND WITH TROUBLES WITH MY CONTACT LENSES, I HAVE BEEN USING NIGHT AND DAY LENSES FROM CIBA VISION THAT ARE SUPPOSED TO BE USED FOR 30 DAYS, NOW I HAVE TO THROW THEM AT LEAST AFTER 3 DAYS OF USE I AM VERY AFRAID BECAUSE WE DON'T HAVE IN ANOTHER COUNTRY, THE INFORMATION I DISCOVER TODAY IN FDA ABOUT ACANTHAMOEBA KERATITIS INFECTIONS POTENTIALLY RELATED TO COMPLETE MOISTUREPLUS MULTIPURPOSE CONTACT LENS SOLUTION MANUFACTURED BY ADVANCED MEDICAL OPTICS AMO. I HAVE GONE TO DOCTORS BEFORE KNOWING THIS, I ALSO PRACTICE AN EYE-ECOGRAPHY BUT NOTHING APPEARED. THERE IS NO TREATMENT, WHAT DO I DO, I WORK FOR 28 YEARS AS CHIEF PHARMACIST, AND I MUST SOLVE THIS PROBLEM AND GET MY EYES CURED. PLEASE HELP ME. DOSE: 5 ML. FREQUENCY: NIGHT. ROUTE: OPHTHALMIC. DATES OF USE APPROX ONE MONTH IN 2007, 36 DAYS. DIAGNOSIS: FOR MY CONTACT LENSES IN THE NIGHT. EVENT ABATED AFTER USE STOPPED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMO COMPLETE MOISTUREPLUS SOLUTION MOISTURE SOLUTIONS FOR CONTACT LENSES LPN ADVANCED MEDICAL OPTICS AB 02934

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other