BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE TRUEYE NARAFILCON A

    MDR report key: 1871038 · Received October 8, 2010

    Report

    Report Number
    1033553-2010-00109
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 21, 2010
    Report Date
    October 8, 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 EVAL WILL BE PERFORMED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, OUR (B)(6) AFFILIATE WAS NOTIFIED THAT A PT WHO WORE 1-DAY TRUEYE NARAFILCON A CONTACT LENSES (NARAFILCON A PRODUCT IS NOT MARKETED IN THE U.S.) WAS DIAGNOSED AND TREATED FOR A CORNEAL ULCER. ON (B)(6) 2010, THE TREATING EYE DOCTOR WAS CONTACTED AND PROVIDED ADDITIONAL INFO. THE PT INITIALLY PRESENTED (B)(6) 2010; DOCTOR NOTED CORNEAL ULCER AND ABSCESS OD. THE PT WAS INSTRUCTED TO D/C CONTACT LENS WEAR AND TREATED WITH VIGAMOX AND BESTRON DROPS. F/U (B)(6) 2010: IMPROVING. F/U (B)(6) 2010: RESOLVED. NO ADDITIONAL INFO IS EXPECTED TO BE RECEIVED. THE PRODUCT IN QUESTION IS NOT AVAILABLE FOR RETURN FOR EVAL. THE LOT NUMBER OF THE PRODUCT IN QUESTION IS UNK. BASED ON THE LIMITED INFO AVAILABLE, NO FURTHER INVESTIGATION CAN BE CONDUCTED AT THIS TIME. IF ADDITIONAL INFO IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. ALL 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention