BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 1823399 · Received August 25, 2010

    Report

    Report Number
    1610287-2010-00106
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    February 24, 2010
    Report Date
    February 24, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT #: 171579F. ADDITIONAL EXPIRATION DATE: 01/31/2012. MANUFACTURING DATE FOR LOT NUMBER 171579F IS 01/14/2010. EVALUATION SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED. IT IS UNK IF THE PRODUCT WAS USED ACCORDING TO LABELED INDICATIONS. BATCH RECORDS WERE REVIEWED FOR LOT 171578F AND 171579F AND NO DEVIATIONS WERE IDENTIFIED. CHEMISTRY AND MICROBIAL RESULTS, ENVIRONMENTAL, UTILITY, BIOBURDEN, AND SANITIZATION RECORDS WERE ALSO REVIEWED AND FOUND TO BE ACCEPTABLE. ONE WHOLE DEAD ANT WAS FOUND FLOATING IN LOT 171578F. LOTS 171578F AND 171579F MET ALL RELEASE CRITERIA PRIOR TO PRODUCT RELEASE. THERE ARE NO SIMILAR REPORTS FOR THESE LOTS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED VIA MAIL ON 08/02/2010 AND 08/19/2010; VIA PHONE 08/02/2010 AND 08/18/2010. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER ON 08/02/2010. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "INFECTION" (INFECTION). PRODUCT PROBLEM(S): "ANT IN BOTTLE" (CONTAMINATION DURING USE. A CONSUMER REPORTED SHE EXPERIENCED AN EYE INFECTION FOLLOWING THE USE OF THIS PRODUCT. SHE STATED SHE WENT TO THE DOCTOR AND WAS PRESCRIBED AN OPHTHALMIC SUSPENSION. SHE NOTED SHE HAS BEEN USING THIS PRODUCT FOR 10 YEARS WITHOUT ANY PROBLEMS. THE CONSUMER REPORTED SHE DISCONTINUED CONTACT LENS WEAR AND HER SYMPTOMS HAVE RESOLVED.

    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 171578F

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention