BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 2031377 · Received March 23, 2011

    Report

    Report Number
    1610287-2011-00032
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 21, 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

    EVALUATION SUMMARY: NO LOT CODE OR SAMPLE WAS PROVIDED BY THE CUSTOMER. NO FURTHER EVALUATION OR ROOT CAUSE ANALYSIS CAN BE CONDUCTED AT THIS TIME. NO ROOT CAUSE COULD BE DETERMINED. ADDITIONAL INFORMATION WAS REQUESTED VIA MAIL ON 02/21/2011; VIA FAX ON 02/21/2011; VIA PHONE ON 03/15/2011 AND 03/16/2011. AT THIS TIME, ADDITIONAL INFORMATION HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMOLOGIST REPORTED A PATIENT WITH KERATITIS FOLLOWING THE USE OF THIS PRODUCT. ON (B)(6) 2011, ADDITIONAL INFORMATION WAS RECEIVED FROM THE TECHNICIAN WHO STATED THEY HAVE BEEN UNABLE TO REACH THE PATIENT FOR FOLLOW-UP. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS IS THE SIXTH OF SEVEN COMPLAINTS REPORTED BY THIS PHYSICIAN. SIX OF THE SEVEN REQUIRED AN MDR.

    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