BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE TRUEYE, NARAFILCON A

    MDR report key: 1836422 · Received September 13, 2010

    Report

    Report Number
    1033553-2010-00059
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    July 30, 2010
    Report Date
    September 13, 2010
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K073485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    OUR (B)(4) AFFILIATE REPORTS A PT DEVELOPED IRITIS WHILE WEARING 1-DAY ACUVUE TRUEYE LENSES (NARAFILCON A). THE PT WAS SWITCHED FROM 1-DAY ACUVUE MOIST LENSES TO 1-DAY ACUVUE TRUEYE ON (B)(6)2010. THE PT WAS INITIALLY SEEN ON (B)(6)2010 FOR OU INJECTION. THE PT WAS DIAGNOSED WITH SPK OU AND IRITIS OD. CELLS WERE OBSERVED IN THE OD ANTERIOR CHAMBER AND THE PT HAD A CILIARY REACTION. THE PT WAS PRESCRIBED MEDS FOR THE OD ONLY, GATIFLOXACIN AND BESTRON Q2H SINCE AN INFECTION WAS SUSPECTED, TARIVID BID AND MYDRIN-P QD. AT THE TIME THE PT'S CORRECT VA OD WAS 1.2 (APPROX 20/20). THE PT RETURNED ON (B)(6)2010 AND THE SYMPTOMS WERE RESOLVED. THE LOT NUMBER OF THE 1-DAY TRUEYE LENSES OD WAS A RECALLED LOT. THE EYE CARE PROFESSIONAL (ECP) BELIEVES THIS INJURY WAS RELATED TO THE RECALLED PRODUCT. THE 1-DAY ACUVUE TRUEYE LENSES, NARAFILCON A, ARE NOT MARKETED IN THE U.S. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALS THE FOLLOWING: 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. IF ADDITIONAL INFORMATION IS REC'D, WE WILL REPORT IT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN EXECUTIVE MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1-DAY ACUVUE TRUEYE, NARAFILCON A SOFT CONTACT LENS LPL VISTAKON NA 4922510110

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other