BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE MOISTURE PLUS

    MDR report key: 859803 · Received May 30, 2007

    Report

    Report Number
    MW5002305
    Event Type
    Malfunction
    Date Received
    May 30, 2007
    Report Date
    May 30, 2007
    Manufacturer
    AMO, INC.
    Product Code
    LPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EYE IRRITATION AND INFECTION. THOUGHT IT WAS DUE TO CONTACT LENS. I'VE BEEN USING COMPLETE MOISTURE PLUS FOR YEARS NOW AND FIRST REACTION WAS ABOUT 3 YRS OR SO AGO. MY EYES WERE COMPLETELY IRRITATED AND HAD TO TAKE MEDICATION FOR IT. IT BOTHERED ME SO MUCH THAT WHEN I BLINKED IT HURT. DOC JUST GAVE ME MEDS AND IT CLEARED IN FEW DAYS. THAT WAS WORST REACTION. MOST RECENT WAS THIS LAST WEEK BEFORE I HEARD OF RECALL. EYES JUST GOT IRRITATED AGAIN WHEN DRIVING HOME IN THE EVENING. COULD HARDLY SEE CLEARLY FROM RIGHT EYE. EYE IS BETTER TODAY BUT STILL FEELS LITTLE ODD. I'LL BE GOING FOR CHECKUP THIS WEEKEND WHEN I GET A CHANCE. DATES OF USE: 2003 - 2007. EVENT ABATED AFTER USE STOPPED: NO. SEVERAL DROPS TO CLEAN CONTACT - ALMOST DAILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE MOISTURE PLUS COMPLETE MOISTURE LPN AMO, INC. AB04711

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR