BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 1905569 · Received November 19, 2010

    Report

    Report Number
    1610287-2010-00139
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 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
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RECEIVED FOR EVAL. IT IS UNK IF THE PRODUCT WAS USED ACCORDING TO LABELED INDICATIONS. BATCH RECORDS WERE REVIEWED FOR LOT 181343F AND NO DEVIATIONS WERE IDENTIFIED. CHEMISTRY AND MICROBIAL RESULTS, ENVIRONMENTAL, UTILITY, BIOBURDEN, AND SANITIZATION RECORDS WERE ALSO REVIEWED AND FOUND TO BE ACCEPTABLE. LOT 181343F MET ALL RELEASE CRITERIA PRIOR TO PRODUCT RELEASE. THERE ARE NO SIMILAR REPORTS FOR THIS LOT. ADDITIONAL INFO WAS REQUESTED VIA MAIL ON (B)(6) /2010; AND VIA PHONE ON 11/04/2010. AT THIS TIME ADDITIONAL INFO HAS NOT BEEN RECEIVED FROM THE CONSUMER. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED SHE EXPERIENCED BURNING FOLLOWING THE USE OF THIS PRODUCT. SHE STATED SHE RINSED HER LENSES, INSERTED THEM AGAIN AND EXPERIENCED THE SAME SYMPTOMS. SHE STATED THE BURNING WOULD NOT GO AWAY AND SHE WENT TO HER DOCTOR. SHE REPORTED HER DOCTOR TOLD HER, SHE HAD A CHEMICAL BURN AND WAS PRESCRIBED AN ANTIBIOTIC. ON 11/04/2010, ADDITIONAL INFO WAS RECEIVED FROM THE CONSUMER STATING THE EVENT OCCURRED UPON INITIAL USE OF THIS BOTTLE. SHE REPORTED SHE ATTEMPTED TO WEAR HER CONTACTS ONE TIME SINCE THE EVENT OCCURRED AND SHE WAS SUCCESSFUL USING ANOTHER BOTTLE OF THIS PRODUCT. SHE STATED SHE FINISHED THE ANTIBIOTIC AND SHE IS DOING A LITTLE BETTER. SHE NOTED SHE STILL FEELS LIKE THERE IS A FILM OVER HER RIGHT EYE CAUSING SOME BLURRY VISION. SHE REPORTED SHE WILL BE RETURNING TO THE DOCTOR. 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 181343F

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other SOFT CONTACT LENSES - BRAND UNK