BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH MULTI-PURPOSE DISINFECTING SOLUTION

    MDR report key: 978985 · Received January 14, 2008

    Report

    Report Number
    1610287-2008-00002
    Event Type
    Injury
    Date Received
    January 14, 2008
    Date of Event
    December 15, 2007
    Report Date
    December 15, 2007
    Manufacturer
    ALCON - FORT WORTH, ALCON LABORATORIES, INC.
    Product Code
    LPN
    PMA / PMN Number
    K050729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. PRODUCT HISTORY COULD NOT BE REVIEWED BECAUSE REPORTER HAS NOT PROVIDED LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED FROM CONSUMER ON 12/15/2007, 12/17/2007, 12/18/2007, 01/08/2008, AND 01/09/2008. INFORMATION WAS PROVIDED BY CONSUMER ON 12/15/2007, 12/17/2007, AND 01/09/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTED SHE EXPERIENCED OCULAR BURNING, PAIN, SWELLING AND SHE COULD NOT OPEN HER EYES OR SEE AFTER USING THIS PRODUCT. SHE STATED SHE USED PRODUCT FOR THE FIRST TIME THE PREVIOUS DAY. SHE VISITED AN EMERGENCY ROOM WHERE SHE WAS DIAGNOSED WITH "CHEMICAL BURNS" AND TREATED WITH MEDICATIONS (NOT SPECIFIED), PER CONSUMER. TWO DAYS AFTER ONSET OF SYMPTOMS, SHE REPORTED HER EYES FELT BETTER. IN 2008, THE CONSUMER STATED SHE VISITED HER PHYSICIAN AGAIN AND HER EYES ARE ALL RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FREE REPLENISH MULTI-PURPOSE DISINFECTING SOLUTION LENS CARE DISINFECTING SOLUTIONS LPN ALCON - FORT WORTH, ALCON LABORATORIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Required Intervention