BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE TRUEYE NARAFILCON A

    MDR report key: 1936033 · Received December 13, 2010

    Report

    Report Number
    1033553-2010-00156
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 2, 2010
    Report Date
    December 13, 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. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    OUR (B)(4) AFFILIATE RECEIVED INFO FROM A CONTACT LENS (CL) SALES SHOP ON (B)(6) 2010 INDICATING A PT DEVELOPED A CORNEAL ULCER IN SEPTEMBER WHILE WEARING 1-DAY ACUVUE TRUEYE CONTACT LENSES (NARAFILCON A). NARAFILCON A CONTACT LENSES ARE NOT MARKETED IN THE UNITED STATES. THE BANDO EYE CLINIC, WHERE THE PT RECEIVED TREATMENT, WAS CONTACTED ON (B)(6) 2010 AND AN APPOINTMENT FOR A FACE-TO-FACE INTERVIEW WAS SCHEDULED FOR (B)(6) 2010. ON (B)(6) 2010, AN ASSOCIATE FROM OUR (B)(4) AFFILIATE MET THE TREATING ECP AND RECEIVED THE FOLLOWING INFO: THE PT WAS INITIALLY SEEN ON (B)(6) 2010. THE PT COMPLAINED OF RIGHT EYE (OD) PAIN IN THE MIDDLE OF THE NIGHT ON (B)(6) 2010. THE PT ALSO COMPLAINED OF OD REDNESS AND A WHITE DOT IN THE OD. THE PT WAS DIAGNOSED WITH A 0.5 MM CORNEAL INFILTRATE OD. THE INFILTRATE WAS PERIPHERAL AND LOCATED AT 4 O'CLOCK. THE ECP PRESUMED THE INFILTRATE WAS INFECTIOUS, BUT THE INFILTRATE WAS NOT CULTURED. THE PT'S VA WAS NOT MEASURED, BUT THE ECP NOTED THAT THE OD VA WAS NOT AFFECTED. THE PT WAS TREATED WITH GATIFLO, AVELOX AND HYALEIN EYE DROPS AND MAXIPIME 1G IV. ON (B)(6) 2010 THE PT RETURNED TO BANDO EYE CLINIC. THE PT STILL HAD A LITTLE DISCOMFORT. THERE WAS A LEUCOMA WHICH WAS SMALLER THAN THE CORNEAL INFILTRATE. THE PT CONTINUED TREATMENT WITH THE EYE DROPS. THE PT'S VA WAS NOT MEASURED. ON (B)(6) 2010, THE PT RETURNED TO THE EYE CLINIC. THE PT'S CONDITION HAD MUCH IMPROVED. THE PT'S VA WAS NOT MEASURED. THE PT CONTINUED TO BE TREATED WITH GATIFLO AND HYALEIN EYE DROPS. THE PT REQUESTED TO RESUME CL WEAR AND WAS PRESCRIBED 1-DAY ACUVUE MOIST CONTACT LENSES AND ALLOWED TO WEAR THEM FOR A SHORT TIME. ON (B)(6) 2010, THE PT RETURNED TO THE EYE CLINIC. THERE WAS A SLIGHT, RESIDUAL, CORNEAL SCAR. THE ECP DETERMINED THAT THE PT RECOVERED AND THE PT WAS PRESCRIBED 1-DAY ACUVUE MOIST CONTACT LENSES. THE PRODUCT AND LOT# WERE NOT PROVIDED. IF ADDITIONAL INFO IS RECEIVED, 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other| R