BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 2192434 · Received July 27, 2011

    Report

    Report Number
    1610287-2011-00078
    Event Type
    Injury
    Date Received
    July 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ALCON - FORT WORTH / ALCON LABS, INC.
    Product Code
    LPN
    PMA / PMN Number
    K050729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT NUMBER 173522F. EXPIRATION DATE FOR LOT NUMBER 173522F IS 09/30/2010. MFG DATE FOR LOT NUMBER 173522F IS 09/29/2009. EVAL SUMMARY: NO SAMPLE WAS RETURNED BY THE CUSTOMER. THE COMPLAINT HISTORY WAS REVIEWED FOR BOTH LOT NUMBERS FOR LOT NUMBER 175711F, THERE WERE THREE OTHER COMPLAINTS OF THIS NATURE REPORTED AND FOR LOT NUMBER 173522F ONE OTHER COMPLAINT OF THIS NATURE. 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 RETENTION SAMPLE WAS TESTED BY QA CHEMISTRY FOR BOTH LOT NUMBERS FOR OSMOLALITY, COLOR, AND CLARITY AND RESULTS WERE FOUND TO BE ACCEPTABLE. BOTH LOT NUMBERS MET ALL RELEASE CRITERIA PRIOR TO PRODUCT RELEASE. NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TWO CASES OF CONJUNCTIVITIS AND REDNESS FOLLOWING THE USE OF THIS PRODUCT. AN ANTIBIOGRAM CONFIRMED SERRATIA MARCESCENS AND THE PTS WERE TREATED WITH TWO ANTIBIOTICS. IT WAS REPORTED THE PTS' SYMPTOMS HAVE RESOLVED. 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 LABS, INC. NA 175711F

    Patients

    Seq Age Sex Outcome Treatment
    1 Other