BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 2031634 · Received March 16, 2011

    Report

    Report Number
    1610287-2011-00025
    Event Type
    Injury
    Date Received
    March 16, 2011
    Report Date
    February 14, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO LOT CODE OR SAMPLE WAS PROVIDED BY THE CUSTOMER. NO FURTHER EVAL OR ROOT CAUSE ANALYSIS CAN BE CONDUCTED AT THIS TIME. NO ROOT CAUSE COULD BE DETERMINED. ADDITIONAL INFO WAS REQUESTED VIA MAIL ON 02/15/2011; VIA FAX ON 02/15/2011; VIA PHONE ON 02/21/2011. AT THIS TIME, ADDITIONAL INFO HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMOLOGIST REPORTED A PT WHO EXPERIENCED SEVERE KERATITIS FOLLOWING THE USE OF THIS PRODUCT. SHE STATED SHE IS TREATING THE EVENT WITH AGGRESSIVE LUBRICATION. ADDITIONAL INFO HAS BEEN REQUESTED. THIS REPORT IS FOR PT 3 OF 7.

    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 Other