BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 1905586 · Received November 19, 2010

    Report

    Report Number
    1610287-2010-00143
    Event Type
    Injury
    Date Received
    November 19, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ALCON - FORTH 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: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED ON 11/05/2010. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED CORNEAL INFILTRATIVE EVENTS (CIES) IN SOME OF HIS PTS WITH USE OF THIS PRODUCT. HE STATED THAT UPON FURTHER REVIEW OF HIS PT DATA, THESE EVENTS WERE ALSO OBSERVED IN PTS WHO WERE USING OTHER SOLUTIONS. THE OPTOMETRIST NOTED THE EVENTS COULD BE RELATED TO THE ALLERGY SEASON. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FREE REPLENISH LENS CARE DISINFECTING SOLUTIONS LPN ALCON - FORTH WORTH / ALCON LABORATORIES, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other