BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 2248960 · Received September 9, 2011

    Report

    Report Number
    1610287-2011-00096
    Event Type
    Injury
    Date Received
    September 9, 2011
    Report Date
    August 10, 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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: PRODUCT EVAL: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVAL. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. REPLENISH SOLUTIONS IS COMPOUNDED IN FWN IN STAINLESS STEEL TANKS. (B)(4). RAW MATERIAL TESTING IS PERFORMED PER REQUIREMENTS FOR ALL LENS CARE PRODUCTS. ALL LENS CARE PRODUCT UNDERGO MICROBIAL AND CHEMISTRY IN PROCESS AND FINISHED PRODUCT TESTING. A REVIEW OF THE STABILITY DATA FOR ALL REPLENISH LOTS CURRENTLY ENROLLED IN THE STABILITY PROGRAM WAS CONDUCTED AND ALL LOTS REMAIN WITHIN SPECIFICATION THROUGH PRODUCT SHELF LIFE. ALL COMPOUNDING, FILLING MBRS ARE SUBJECTED TO 2 INDEPENDENT REVIEWS. IN ADDITION, PRIOR TO PRODUCT RELEASE, THE FOLLOWING ARE REVIEWED: ALL CHEMISTRY AND MICROBIAL FINISHED PRODUCT RESULTS, ENVIRONMENTAL, UTILITY, BIOBURDEN RECORDS AND SANITIZATION RECORDS. THE PRIMARY COMPONENTS (BOTTLES AND CLOSURES) ARE PRODUCED UNDER CONTROLLED CONDITIONS AND ARE DOUBLE BAGGED AND PLACED INTO SHIPPERS FROM THE SUPPLIER. THOSE SHIPPERS AND THE COMPONENTS INSIDE ARE STERILIZED PRIOR TO BEING SENT TO ALCON. ALL INCOMING COMPONENTS ARE INSPECTED BY QA AND ARE VERIFIED TO MEET DESIGN CRITERIA VIA DIMENSIONAL ANALYSIS AND ATTRIBUTE INSPECTION PRIOR TO DISPOSITION. MFG AREAS ARE ROUTINELY MONITORED FOR ENVIRONMENTAL (TEMPERATURE, HUMIDITY, AIR PRESSURE, VIABLE AND NONVIABLE). (B)(4). AT THIS TIME NO ROOT CAUSE CAN BE DETERMINED. ADDITIONAL INFO WAS REQUESTED (B)(4) 2011 AND (B)(4) 2011 BY FAX, PHONE AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A OPTOMETRIST REPORTED 20 PLUS PTS WERE DIAGNOSED WITH KERATITIS FOLLOWING USE OF THIS PRODUCT. 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ACCUVUE OASYS SOFT CONTACT LENSES