BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 335372 · Received May 25, 2001

    Report

    Report Number
    MW1022020
    Event Type
    Other
    Date Received
    May 25, 2001
    Date of Event
    April 27, 2001
    Report Date
    May 25, 2001
    Manufacturer
    *
    Product Code
    LPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR USED BOSTON ADVANCE COMFORT FORMULA CONDITIONING SOLUTION 3031004, EXP 08-02, GH 0131 - AND SUFFERED A CORNEAL REACTION. THE SOLUTION WAS TOXIC AND BURNED IMMEDIATELY. RPTR HAD BLURRED VISION AND COULD NOT USE CONTACTS FOR 36 HRS. BEING A SCIENTIST, RPTR DECIDED TO TEST THE SOLUTION AGAIN, AND IMMEDIATE BURNING OCCURRED. RPTR HAD SALINE READY IMMEDIATELY TO WASH IT OUT AND SUFFERED NO CONSEQUENCES WITH THE RECHALLENGE. THE SOLUTION IN THIS BOTTLE IS NOT THE CORRECT ONE, AND RPTR IS CONCERNED MANY OTHER CONTACT LENS WEARERS ARE SUFFERING. RPTR WEARS RIGID GAS PERMEABLE CONTACT LENSES, AND HAS BEEN USING THIS BRAND OF SOLUTION FOR FOUR YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24520 * * LPN * * 3031004/GH0131

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other