BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE 2 BRAND

    MDR report key: 2161984 · Received July 11, 2011

    Report

    Report Number
    1033553-2011-00046
    Event Type
    Injury
    Date Received
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT PRODUCT WAS NOT AVAILABLE FOR EVALUATION BUT WAS REQUESTED BACK IF IT IS AVAILABLE. A LOT HISTORY REVIEW WAS REQUESTED. THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. LOT L000ZNX WAS MANUFACTURED UNDER NORMAL CONDITIONS. DEVICE LABELING SINGLE USE OR REUSE. DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM OUR (B)(4) AFFILIATE ON (B)(6) 2011. ON (B)(6) 2011, OUR (B)(4) AFFILIATE INFORMED JOHNSON AND JOHNSON (B)(4) THAT THIS INFORMATION WAS FIRST RECEIVED BY JOHNSON AND JOHNSON LEGAL DEPARTMENT IN (B)(4) ON (B)(6) 2011. THIS INFORMATION INDICATES A PATIENT WAS WEARING ACUVUE 2 CONTACT LENSES AND DEVELOPED AN INFECTION. THE REPORT STATED "(B)(6) HAD INFECTION WITH THE BACTERIUM, CAUSING HIM CORNEAL ULCER. ALMOST LOST HIS SIGHT." THE WEAR AND REPLACEMENT SCHEDULE AND TYPE OF CLEANING SOLUTION WERE NOT INDICATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, INCLUDING THE INITIAL NOTIFICATION DATE THAT OUR FIRM RECEIVED THE COMPLAINT. ANY ADDITIONAL INFORMATION WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE 2 BRAND SOFT CONTACT LENS LPL VISTAKON NA L000ZNX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other