BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 2141181 · Received June 22, 2011

    Report

    Report Number
    1610287-2011-00066
    Event Type
    Injury
    Date Received
    June 22, 2011
    Report Date
    May 23, 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
    VT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVAL. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE, THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADD'L INFO WAS REQUESTED BY FAX AND MAIL ON 5/24/2011, 6/16/2011 AND BY PHONE ON 5/24/2011, 06/15/2011, 06/16/2011 AND 06/20/2011. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED SEVERAL PTS WERE SEEN FOR DISCOMFORT FOLLOWING USE OF THIS PRODUCT. THE OPTOMETRIST STATED THAT UPON EXAMINATION HE FOUND KERATITIS. ADD'L INFO 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 NI Other