BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 1956383 · Received January 7, 2011

    Report

    Report Number
    1610287-2011-00001
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 8, 2010
    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
    PA, 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 CAN BE CONDUCTED AT THIS TIME. NO ROOT CAUSE COULD BE DETERMINED. ADD'L INFO WAS REQUESTED VIA E-MAIL ON 12/08/2010 AND 01/04/2011; VIA PHONE ON 12/08/2010 AND 12/23/2010. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED TWO PTS WHO EXPERIENCED DIFFUSE CORNEAL INFILTRATES AND RED EYES FOLLOWING THE USE OF THIS PRODUCT AND SILICONE HYDROGEL CONTACT LENSES. HE REPORTED HE TREATED THE PTS WITH AN ANTIBIOTIC AND THEIR SYMPTOMS ARE RESOLVING. 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 Other ACUVUE OASYS CONTACT LENSES