BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 2230546 · Received August 12, 2011

    Report

    Report Number
    1610287-2011-00075
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 30, 2011
    Manufacturer
    ALCON FORT WORTH / ALCON LABORATORIES
    Product Code
    LPN
    PMA / PMN Number
    K050729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE COMPLAINT SAMPLE WAS NOT RETURNED BY THE CUSTOMER. THE COMPLAINT HISTORY WAS REVIEWED FOR THIS LOT AND THERE WAS ONE OTHER COMPLAINT FOR RED EYE. IRRITATION WAS REPORTED. REVIEW OF THE COMPONDING AND FILLING MDRS DID NOT SHOW ANY ANOMALIES THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE CHEMISTRY AND MICROBIAL FINISHED PROD RESULTS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THE ENVIRONMENTAL, UTILITY, BIOBURDEN, AND SANITAZION RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THIS LOT MET ALL RELEASE CRITERIA PRIOR TO PRODUCT RELEASE. ADD'L INFO WAS REQUESTED BY FAX AND MAIL ON 07/05/2011, AND BY PHONE ON 07/01/2011. A COMPLETED QUESTIONNAIRE WAS RECEIVED FROM THE DR ON 07/13/2011. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED, SHE DEVELOPED SEVERE DRY EYE AND INFLAMMATION FOLLOWING THE USE OF THIS PRODUCT. A COMPLETED QUESTIONNAIRE FROM THE OPTOMETRIST WAS RETURNED ON (B)(6) 2011, WHO DIAGNOSED THE PT WITH KERATITIS (OS). THE OPTOMETRIST REPORTED THAT THE EVENT RESOLVED FOLLOWING TREATMENT WITH A COMBINATION STEROID AND ANTIBIOTIC EYE DROP. ON (B)(6) 2011, THE CONSUMER REPORTED THE EVENT HAD RESOLVED,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FREE REPLENISH LENS CARE DISINGECTING SOLUTIONS LPN ALCON FORT WORTH / ALCON LABORATORIES NA 180865F

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other ALLEGRA| ADVAIR| CIBA SOFT CONTACT LENSES