BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 1983129 · Received February 4, 2011

    Report

    Report Number
    1610287-2011-00007
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 5, 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
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT #: 174338F. EXP DATE FOR LOT NUMBER 174338F IS 11/30/2011.EVAL 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. ADD'L INFO WAS REQUESTED VIA MAIL ON 01/05/2011 AND 01/31/2011; VIA PHONE ON 01/17/2011. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED, SHE WENT TO THE DOCTOR WITH SYMPTOMS OF DECREASED VISION AND HAVING TROUBLE FOCUSING FOLLOWING THE USE OF THIS PRODUCT. SHE STATED, HER DOCTOR DIAGNOSED HER WITH HOLES IN HER CORNEA. SHE NOTED IT IS GETTING HARDER FOR HER TO READ. SHE REPORTED HER DOCTOR PRESCRIBED HER A STEROID/ANTIBIOTIC COMBINATION FOR 10 DAYS AND REQUESTED SHE DISCONTINUE CONTACT LENS USE FOR 10 DAYS. ADD'L 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 187062F

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other