BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 2063752 · Received April 14, 2011

    Report

    Report Number
    1610287-2011-00040
    Event Type
    Injury
    Date Received
    April 14, 2011
    Date of Event
    March 13, 2011
    Report Date
    March 15, 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
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: VISUAL EXAMINATION. EVALUATION SUMMARY: THE SAMPLE WAS RETURNED BY THE CUSTOMER. A VISUAL EXAMINATION OF THE EXTERIOR OF THE RETURNED SAMPLE SHOWED DUST AND DIRT-LIKE PARTICLES ON THE CAP AND SHOULDER OF THE BOTTLE WHICH MAY INDICATE POOR LENS CARE PRACTICES. THE CAP WAS REMOVED TO OBSERVE THE SOLUTION, THE SOLUTION APPEARED TO HAVE NO VISIBLE PARTICULATES, AND HAD TYPICAL ODOR, COLORING AND CLARITY. THE COMPLAINT HISTORY WAS REVIEWED FOR THIS LOT AND THERE WAS ONE OTHER COMPLAINT REPORTED AND IT WAS FOR EYE IRRITATION. REVIEW OF THE COMPOUNDING AND FILLING MBR'S DID NOT SHOW ANY ANOMALIES THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE CHEMISTRY AND MICROBIAL FINISHED PRODUCT RESULTS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THE ENVIRONMENTAL, UTILITY, BIOBURDEN, AND SANITIZATION RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THIS LOT MET ALL RELEASE CRITERIA PRIOR TO PRODUCT RELEASE. NO ROOT CAUSE CAN BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED SHE EXPERIENCED AN EYE INFECTION AND CONJUNCTIVITIS FOLLOWING THE USE OF THIS PRODUCT. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE CONSUMER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION.

    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 170443F

    Patients

    Seq Age Sex Outcome Treatment
    1 Other