BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 2139201 · Received June 16, 2011

    Report

    Report Number
    1610287-2011-00061
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 19, 2011
    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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION REQUESTED BY MAIL ON 05/19/2011 AND BY PHONE ON 05/19/2011, 06/01/2011, 06/06/2011, AND 06/13/2011. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER'S MOTHER REPORTED THAT HER DAUGHTER EXPERIENCED ITCHING AND CRUSTING OVER HER EYES FOLLOWING USE OF THIS PRODUCT. SHE STATED SHE WAS SEEN BY HER PEDIATRICIAN AND OPHTHALMOLOGIST WHO TOLD HER IT WAS ALLERGY RELATED. THEY FOLLOWED UP WITH AN OPTOMETRIST WHO DIAGNOSED A FUNGAL INFECTION ON HER EYES AND PRESCRIBED AN UNSPECIFIED EYE DROP. THE CONSUMER HAS BEEN USING THE DROPS FOR ABOUT THREE WEEKS AND HER EYES ARE BETTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other BIO INFINITY CONTACT LENSES