BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCED MEDICAL OPTICS, INC

    MDR report key: 858724 · Received May 28, 2007

    Report

    Report Number
    MW5001987
    Event Type
    Injury
    Date Received
    May 28, 2007
    Date of Event
    May 12, 2007
    Report Date
    May 28, 2007
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC
    Product Code
    LPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER USING AMO'S ADVANCED MEDICAL OPTICS COMPLETE MOISTURE PLUS MULTI-PURPOSE SOLUTION FOR SOFT CONTACTS EACH DAY, I EXPERIENCED ALL OF THE SYMPTOMS OF ACANTHAMOEBA KERATITIS INCLUDING LIGHT SENSITIVITY, EYE REDNESS AND TEARING, PAIN, AND THE SENSATION THAT SOMETHING WAS IN MY RIGHT EYE. I SAW AN OPHTHALMOLOGIST ON TUESDAY, MAY 15TH, WHO TOLD ME THAT AN ULCER HAD FORMED ON MY RIGHT EYE DUE TO AN UNKNOWN IRRITANT AND THE INCREASE IN WHITE BLOOD CELLS THAT CAME TO FIGHT IT OFF. I WAS PRESCRIBED NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OPHTHALMIC SUSPENSION USP STERILE EYEDROPS TO USE FOUR TIMES EACH DAY UNTIL MY EYE FELT BETTER. I DID NOT HEAR ABOUT THE VOLUNTARY RECALL OF AMO'S CONTACT SOLUTION OR ACANTHAMOEBA KERATITIS UNTIL AFTER THIS DR APPOINTMENT AND AFTER MY EYE IMPROVED, HOWEVER, I BELIEVE THAT MY SYMPTOMS WERE THOSE OF THIS RARE PARASITIC INFECTION. I SOON PLAN TO CONSULT ANOTHER OPHTHALMOLOGIST WHO WILL BE ABLE TO CONFIRM IF THIS IS TRUE. USED THE LAST PAST SIX MONTHS, ONCE A DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCED MEDICAL OPTICS, INC COMPLETE MOISTURE PLUS MULTI-PURPOSE SOLUTION LPN ADVANCED MEDICAL OPTICS, INC AB02241

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Disability