BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 2212708 · Received August 11, 2011

    Report

    Report Number
    1610287-2011-00073
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 1, 2011
    Report Date
    July 12, 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
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO SAMPLE WAS RETURNED BY THE CUSTOMER. THE COMPLAINT HISTORY WAS REVIEWED FOR THIS LOT AND THERE WERE NO OTHER COMPLAINTS FOR EYE INFECTION REPORTED. REVIEW OF THE COMPOUNDING AND FILLING MBRS 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. A SINGLE, NORMAL, LEVEL I IBA WAS PERFORMED FOR PACKAGING NONCONFORMANCES AND WAS FOUND TO BE ACCEPTABLE. THIS LOT MET ALL RELEASE CRITERIA PRIOR TO PRODUCT RELEASE. ADDITIONAL INFORMATION WAS REQUESTED BY MAIL ON 07/13/2011 AND 08/09/2011 AND BY PHONE ON 07/20/2011 AND 08/01/2011. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT SHE EXPERIENCED AN EYE INFECTION TWO MONTHS AGO FOLLOWING USE OF THIS PRODUCT. SHE STATED THAT WHEN SHE TOOK OFF THE CAP TO FILL HER SMALL TRAVEL BOTTLE A DEAD ANT CAME OUT OF THE BOTTLE. SHE STATED SHE WENT TO THE DOCTOR WHO TREATED HER WITH STEROIDS. SHE ALSO STATED THAT SHE RETURNED TO THE DOCTOR THREE WEEKS LATER AND HER EYES HAD CLEARED UP. 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 - FORT WORTH / ALCON LABORATORIES, INC. NA 17887F

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other