BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE MULTIPURPOSE

    MDR report key: 1210925 · Received October 23, 2008

    Report

    Report Number
    MW5008741
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    June 13, 2008
    Report Date
    October 23, 2008
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS A CONTACT LENS WEARER. IN 2008, I DEVELOPED AN EYE INFECTION. I THOUGHT IT WOULD HEAL ITSELF. MY EYE WAS SWOLLEN, TEARING AND VERY PAINFUL. I WAS UNABLE TO HANDLE THE LIGHT. I WAS UNAWARE THAT I HAD NO VISION OUT OF MY LEFT EYE UNTIL I WENT TO URGENT CARE ON TWO DAYS LATER AND WAS ALSO DIAGNOSED WITH A CORNEAL ULCER. I AM STILL UNDER A DOCTOR'S CARE AND WAS OUT OF WORK FOR 3 WEEKS. I HAVE PERMANENT CORNEAL SCARRING AND AS IT STANDS RIGHT NOW, WILL BE ABLE TO HAVE VISION CORRECTION SURGERY. I AM ALSO UNABLE TO WEAR CONTACTS FOR AT LEAST 6 MONTHS. AT THE TIME OF THIS INCIDENT, I WAS USING AMO COMPLETE MOISTUREPLUS MULTIPURPOSE SOLUTION. I STILL HAVE THE BOTTLE. THE IDENTIFYING INFORMATION IS LOT# AC02777, EXP. 6/09. DOSE OR AMOUNT: A SQUIRT, FREQUENCY: DAILY, ROUTE: OPHTHALMIC. DATES OF USE: 2003 - 2008. DIAGNOSIS OR REASON FOR USE: CONTACT LENS SOLUTION. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE MULTIPURPOSE NONE LPN AC02777

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R