BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE TRUEYE NARAFILCON A

    MDR report key: 1870845 · Received October 6, 2010

    Report

    Report Number
    1033553-2010-00100
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    September 9, 2010
    Report Date
    October 6, 2010
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K073485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 SALES REP REPORTED THE FOLLOWING INFORMATION. A PT DEVELOPED PERIPHERAL CORNEAL ULCERS WHILE WEARING 1 DAY ACUVUE TRUEYE CONTACT LENSES (NARAFILCON A). NARAFILCON A PRODUCT IS NOT MARKETED IN THE U.S. THE FOLLOWING INFORMATION WAS RECEIVED FROM THE TREATING EYE CLINIC ON (B)(6)2010: THE PT BEGAN WEARING 1-DAY ACUVUE TRUEYE LENSES ON (B)(6)2010. ON (B)(6)2010, THE PT REPORTEDLY COMPLAINED OF REDNESS, PAIN AND TEARING OS. THE PT SOUGHT TREATMENT AT THE CLINIC ON (B)(6)2010 AND WAS DIAGNOSED WITH 2 PERIPHERAL CORNEAL ULCERS, ONE LOCATED AT 6 O'CLOCK AND ONE AT SEVEN THIRTY. THE SIZE OF EACH WAS 0.5 MM X 0.5 MM. THE ULCERS WERE NOT CULTURED. THE ECP EXPRESSED AN OPINION THAT THE ULCERS WERE INFECTIOUS. THE PT'S CORRECTED VA OS WAS 0.8 (20/25). THE PT WAS PRESCRIBED CRAVIT AND HYALEIN 0.1% EYE DROPS. THE PT WAS INSTRUCTED TO DISCONTINUE CONTACT LENS WEAR. AS OF THE DATE THIS INFORMATION WAS COLLECTED, THE PT HAD NOT RETURNED FOR A FOLLOW-UP EXAMINATION. THE PRODUCT IN QUESTION IS NOT AVAILABLE FOR EVALUATION. THE LOT HISTORY REVIEW REVEALED THE FOLLOWING: THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATIONS. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. THE LOT WAS PRODUCED UNDER NORMAL CONDITIONS. IF ADDITIONAL INFORMATION IS RECEIVED, WILL REPORT 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 4923770103

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other