BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE MULTI-ACTION SOLUTION

    MDR report key: 2210356 · Received August 9, 2011

    Report

    Report Number
    1610287-2011-00072
    Event Type
    Injury
    Date Received
    August 9, 2011
    Report Date
    July 10, 2011
    Manufacturer
    ALCON - FORT WORTH / ALCON LABORATORIES, INC.
    Product Code
    LPN
    PMA / PMN Number
    P830034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS FOR THE LOT COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THIS PRODUCT IS ENROLLED IN THE STABILITY PROGRAM IN WHICH IT IS TESTED ACCORDING TO THIS PRODUCT'S STABILITY SPECIFICATIONS ON A SET SCHEDULE. ALL COMPOUNDING, FILLING MBRS ARE SUBJECTED TO TWO INDEPENDENT REVIEWS. IN ADDITION, PRIOR TO PRODUCT RELEASE, CHEMISTRY AND MICROBIAL FINISHED PRODUCT RESULTS, ENVIRONMENTAL, UTILITIES, BIOBURDEN RECORDS AND SANITIZATION RECORDS ARE REVIEWED. ALL PRIMARY INCOMING COMPONENTS ARE INSPECTED BY QA AND ARE VERIFIED TO MEET DESIGN CRITERIA VIA DIMENSIONAL ANALYSIS AND ATTRIBUTE INSPECTION PRIOR TO DISPOSITION. MANUFACTURING AREAS ARE ROUTINELY MONITORED FOR ENVIRONMENTAL. THERE WERE NO ADVERSE TRENDS FOR GRADE A PERCENT GROWTH DURING THIS REVIEW PERIOD FOR THE CONTACT LENS CARE PRODUCTION LINES. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A HEALTH PROFESSIONAL REPORTED A PATIENT HAD ACANTHAMOEBA KERATITIS WHILE USING THIS PRODUCT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FREE MULTI-ACTION SOLUTION LENS CARE DISINFECTING SOLUTIONS LPN ALCON - FORT WORTH / ALCON LABORATORIES, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other