BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 2139239 · Received June 17, 2011

    Report

    Report Number
    1610287-2011-00063
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 18, 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
    WI, 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 OF THIS NATURE REPORTED. 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 AT THIS TIME. ADDITIONAL INFO WAS REQUESTED VIA MAIL ON 05/18/2011 AND 06/13/2011; VIA FAX ON 05/18/2011 AND 06/13/2011; VIA PHONE 06/13/2011. A COMPLETED QUESTIONNAIRE WAS RECEIVED FROM THE CONSUMER ON 06/10/2011. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED SHE SOAKED HER RIGHT CONTACT LENS OVERNIGHT AND AROUND 4 PM THE NEXT DAY SHE EXPERIENCED DISCOMFORT. SHE REPORTED SHE REMOVED HER CONTACT LENS AND EXPERIENCED DISCOMFORT, TEARING, BURNING SENSATION, LIGHT SENSITIVITY, RED EYE, IRRITATION, EYELID SWELLING AND EYE PAIN. SHE STATED SHE WENT TO THE DOCTOR ON (B)(6) 2011 AND WAS DIAGNOSED WITH "DAMAGE TO HER EPITHELIAL LAYER AND LENS OF HER EYE." SHE STATED HER DOCTOR DESCRIBED IT AS "BURNED OFF". SHE REPORTED HER DOCTOR PRESCRIBED HER AN ANTIBIOTIC TWO TIMES A DAY AND AN ANTI-INFLAMMATORY MEDICATION. SHE STATED DUE TO THE LIGHT SENSITIVITY SHE NEEDED TO WEAR SUNGLASSES AND COULD NOT USE HER COMPUTER FOR WORK. ADDITIONAL INFO 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 180876F

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other REFRESH OPTIVE 1 DROP EVERY 2 HOURS AS NEEDED| BAUSCH AND LOMB PUREVISION SOFT CONTACT LENSES