BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE MOISTURE PLUS

    MDR report key: 860961 · Received June 2, 2007

    Report

    Report Number
    MW5002380
    Event Type
    Injury
    Date Received
    June 2, 2007
    Date of Event
    May 20, 2007
    Report Date
    June 2, 2007
    Manufacturer
    AMERICAN MEDICAL OPTICS
    Product Code
    LPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A RECURRENT EYE INFECTION! THE FIRST TIME I WENT TO THE EYE DR, HE SAID THAT IT WAS A CASE OF PINK EYE AND PRESCRIBED EYE DROPS AND TOLD ME NOT TO USE MY CONTACTS FOR A WEEK OR SO. THE SECOND TIME IT OCCURRED, MY LEFT EYE BECOME RED AND ITCHY AND THE BOTTOM EYE LID WAS SWOLLEN AND THE EYE DR BELIEVED THAT IT WAS A STY AND PINK EYE AGAIN AND PRESCRIBED MORE EYE MEDICINE! THEN IT WOULD OCCUR EVERY TIME I WORE MY CONTACTS AND LAST FOR A WEEK OR TWO AFTER DISCONTINUING THE USE OF THEM AND WEARING MY GLASSES! I RECEIVED THE CDC WARNING ABOUT THE CONTACT SOLUTION PRODUCED BY AMO NAMED COMPLETE MOISTURE PLUS, I USED SEVERAL OF THEIR PRODUCTS FOR SOAKING MY CONTACTS, DISINFECTING THEM AND ALSO THE LUBRICATION DROPS FOR MY EYES! I HAVE SCHEDULED ANOTHER EYE APPT FOR MONDAY MORNING TO TRY AND RID THE EYE INFECTION!. DOSE: 1/2 FL OZ. FREQUENCY: 1-2 TIMES DAY. ROUTE: INTRAOCULAR. DATES OF USE: PASS 6 MONTHS. DIAGNOSIS OR REASON FOR USE: CONTACT LENS WEARER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE MOISTURE PLUS NONE LPN AMERICAN MEDICAL OPTICS AA02711

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other| S