BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPLETE MOISTUREPLUS LENS SOLUTION

    MDR report key: 859744 · Received May 29, 2007

    Report

    Report Number
    MW5002265
    Event Type
    Other
    Date Received
    May 29, 2007
    Date of Event
    May 21, 2007
    Report Date
    May 29, 2007
    Manufacturer
    AMO ADVANCED MEDICAL OPTICS
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLETE CONTACT LENS SOLUTION: EYE INFECTION DIAGNOSED DIFFERENTLY BY 3 DIFFERENT DOCTORS. INFECTION LAST OF 1 WEEK W/ REDNESS, ITCHING, SENSITIVITY TO LIGHT, SWELLING AND BLURRED VISION. AFTER 2 WEEKS OF ANTIBIOTICS, INFECTION WAS CLEARING UP. DIAGNOSED FIRST AS "CALCIUM DEPOSITS" AND THEN SECOND AS "CORNEAL ULCERS." NEITHER DIAGNOSIS SEEMED CONFIDENT. I AM NOW REQUESTING MY RECORD BACK TO CHECK THE CHANCE OF KERATITIS ASSOCIATED WITH THE RECALLED SOLUTION. I HAVE BEEN USING THIS SOLUTION FOR YEARS. ALSO HAD 2 EYE INFECTIONS LAST MONTH. DATES OF USE 4-5 YEARS. DIAGNOSIS OR REASON FOR USE: CONTACT LENS WEARER. EVENT ABATED AFTER USE: YES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other TAKING CONTACTS IN/OUT EVERY DAY-OPHTHALMIC