BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 2020337 · Received March 11, 2011

    Report

    Report Number
    1610287-2011-00021
    Event Type
    Injury
    Date Received
    March 11, 2011
    Report Date
    February 7, 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

    EVAL SUMMARY: NO LOT CODE OR SAMPLE WAS PROVIDED BY THE CUSTOMER. THEREFORE, NO FURTHER EVAL OR ROOT CAUSE ANALYSIS CAN BE CONDUCTED AT THIS TIME. NO ROOT CAUSE COULD BE DETERMINED AT THIS TIME. ADD'L INFO WAS REQUESTED VIA EMAIL ON 02/07/2011; VIA MAIL ON 02/07/2011; VIA PHONE ON 03/02/2011. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER INITIALLY REPORTED SHE EXPERIENCED AN ALLERGIC REACTION FOLLOWING THE USE OF THIS PRODUCT. ON (B)(6) 2011, THE CONSUMER REPORTED SHE WAS DIAGNOSED BY HER PHYSICIAN WITH CORNEAL INFILTRATES AND EXPERIENCED EYE DISCOMFORT. SHE STATED SHE IS NOW USING ANOTHER PRODUCT AND HER SYMPTOMS HAVE RESOLVED. 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 26 YR Other