BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMO COMPLETE MOISTURE PLUS MULTIPURPOSE SOLUTION

    MDR report key: 863841 · Received June 4, 2007

    Report

    Report Number
    MW5002499
    Event Type
    Injury
    Date Received
    June 4, 2007
    Date of Event
    September 13, 2006
    Report Date
    June 4, 2007
    Manufacturer
    ADVANCED MEDICAL OPTICS
    Product Code
    LPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SINCE 2006, I BEGAN USING EXCLUSIVELY THE AMO COMPLETE MOISTURE PLUS MULTIPURPOSE SOLUTION. TWO MONTHS LATER, I BEGAN WITH REDNESS IN BOTH EYES, BUT PRIMARILY IN MY LEFT EYE. I THEN BEGAN TO EXPERIENCE PAIN AND A FEELING AS IF SOMETHING WAS IN MY EYE WITH INCREASED TEARING FROM THE EYES AND LIGHT SENSITIVITY. I REMOVED MY LENSES OUT AND BEGAN WEARING MY GLASSES FULL TIME. I WENT TO THE OPHTHALMOLOGIST WHO DIAGNOSED ME WITH A KERATITIS IN BOTH EYES BUT THE LEFT EYE WAS MUCH WORSE THAN THE RIGHT. I WAS IMMEDIATELY BEGUN ON LONG TERM STEROID AND ANTIBIOTIC DROPS. SHORTLY AFTERWARDS, I NOTICED A MAJOR DECREASE IN MY VISION WITH THE INABILITY TO WEAR MY GLASSES ANYMORE. AFTER SEVERAL MONTHS, MY VISION STABILIZED AND NEW GLASSES LENSES WERE PRESCRIBED WITH MY HAVING LOST OVER A 1.5 DIOPTERS OF VISION IN MY L EYE. AT THE PRESENT TIME, I AM STILL UNABLE TO WEAR ANY CONTACT LENSES AS PER MY OPHTHALMOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMO COMPLETE MOISTURE PLUS MULTIPURPOSE SOLUTION NONE LPN ADVANCED MEDICAL OPTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other| R CILOXAN OPHTHALMIC DROPS| PREDNISOLONE OPHTHALMIC DROPS