BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE DEFINE

    MDR report key: 1870809 · Received October 6, 2010

    Report

    Report Number
    1033553-2010-00095
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    May 18, 2010
    Report Date
    October 6, 2010
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVALUATION PERFORMED.

    Description of Event or Problem · 1

    OUR (B)(4) AFFILIATE REPORTS THAT ON (B)(6)2010 A PT REPORTED EXPERIENCING REDNESS AND PAIN IN BOTH EYES (OU), CONSULTING AN EYE CARE PROFESSIONAL (ECP) AND BEING TREATED FOR CORNEAL ULCERS OU. THE PT REPORTED WEARING 1-DAY ACUVUE DEFINE CONTACT LENSES (CL) OU AT THE TIME OF THE EVENT. THIS REPORT IS RELATED TO THE EVENT FOR THE RIGHT EYE (OD). ON 10/05/2010, AN INTERVIEW WAS CONDUCTED; THE TREATING ECP CONFIRMED THAT THE PT PRESENTED (B)(6)2010 WITH C/O NOT BEING ABLE TO WEAR CL'S AND REDNESS OU. ECP NOTED "PERIPHERAL CORNEAL ULCERS LOCATED BETWEEN THE CORNEA AND THE CONJUNCTIVA, AT ANGLE OF 90 DEGREES IN OD AND 180 DEGREES IN OS." NO CULTURE WAS PERFORMED BUT THE ULCERS WERE DETERMINED TO BE INFECTIOUS. THE PT'S VA WAS NOT MEASURED. THE PT WAS TREATED WITH VIGAMOX AND FLUMETHOLON DROPS (GTTS), INSTRUCTED TO D/C CL WEAR AND TO RETURN TO THE CLINIC IF SYMPTOMS WORSENED. F/U (B)(6)2010: TARIVID EYE OINTMENT WAS PRESCRIBED. F/U (B)(6)2010: CONTINUE VIGAMOX AND FLUMETHOLON GTTS AND TARIVID OINTMENT. F/U (B)(6)2010: CONTINUE VIGAMOX AND FLUMETHOLON GTTS. F/U (B)(6)2010: ULCER RESOLVED OD, STILL HAD SLIGHT ULCER OS. THE PT'S CORRECTED VA WAS 1.2 (20/20) OU. CONTINUE VIGAMOX AND FLUMETHOLON GTTS AND TARIVID EYE OINTMENT. F/U (B)(6)2010: CONTINUE VIGAMOX AND FLUMETHOLON GTTS. F/U (B)(6)2010: THE PT HAD RESUMED CONTACT LENS WEAR AGAINST THE ECP'S INSTRUCTION TO CONTINUE TO D/C CL WEAR. THE PT WAS PRESCRIBED CRAVIT AND ECOLICIN GTTS. F/U (B)(6)2010: "CONDITION IMPROVED AND SPK WAS NOTED." THE PT WAS PRESCRIBED HYALEIN GTTS. F/U (B)(6)2010: THE PT DID NOT RETURN TO THE CLINIC ON (B)(6)2010 AS INSTRUCTED. THE ECP CONFIRMED THAT THE PT RECOVERED OU. NO ADDITIONAL INFO IS EXPECTED TO BE RECEIVED. THE PRODUCT IN QUESTION HAS BEEN DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. A LOT HISTORY INDICATED 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. NO FURTHER INVESTIGATION CAN BE CONDUCTED AT THIS TIME. IF ADDITIONAL INFO 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 DEFINE SOFT CONTACT LENS LPL VISTAKON NA 3882800805

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention