BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE TRUEYE NARAFILCON A

    MDR report key: 1870889 · Received October 7, 2010

    Report

    Report Number
    1033553-2010-00103
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    August 6, 2010
    Report Date
    October 7, 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

    THE PRODUCT HAS NOT BEEN RETURNED AND THE LOT NUMBER IS NOT KNOWN AT THIS TIME. IF ADD'L INFO IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN EXECUTIVE MGMT REVIEW MEETINGS.

    Description of Event or Problem · 1

    A PT CONTACTED OUR (B)(4) AFFILIATE AND REPORTED EXPERIENCED PAIN UPON INSERTION OF CONTACT LENS (CL), THIS OCCURRED AROUND (B)(6) 2010. THE PT REPORTED SEEING AN EYE CARE PROFESSIONAL (ECP) ON (B)(6) 2010. THE PT SAID HE/SHE WAS PRESCRIBED MEDICATION AND INSTRUCTED TO D/C LENS WEAR. OUR AFFILIATE CONTACTED THE TREATING EYE CLINIC AND RECEIVED THE FOLLOWING INFO. THE PT WAS INITIALLY SEEN ON (B)(6) 2010. THE PT HAD SLEPT WHILE WEARING 1-DAY TRUEYE LENSES (NARAFLICON A). NARAFILCON A LENSES ARE NOT MARKETED IN THE U.S. THE TREATING CLINIC HAD NOT PRESCRIBED THE LENSES FOR THIS PT. THE PT WAS DIAGNOSED WITH THE FOLLOWING IN THE OS: CONJUNCTIVITIS, CORNEAL ULCER, IRITIS AND HORDEOLUM. THE PT WAS PRESCRIBED VIGAMOX AND SAWACILLIN. THE PT RETURNED ON (B)(6) 2010 AND WAS PRESCRIBED VIGAMOX, BESTRON (EVERY HOUR) ERYCOLI OPHTHALMIC OINTMENT QHS AND CRAVIT EVERY MORNING. THE PT RETURNED AGAIN ON (B)(6) 2010. ON (B)(6) 2010, THE PT WAS INSTRUCTED TO USE VIGAMOX AND TO CONTINUE USING BESTRON AND CONTINUE USING THE MEDICATIONS UNTIL FINISHED. THE PT WAS INSTRUCTED TO RETURN FOR F/U. AT THE TIME OUR AFFILIATE OBTAINED THIS INFO, (B)(6) 2010, THE PT HAD NOT RETURNED FOR A F/U VISIT. ON (B)(6) 2010, THE PT WAS CONTACTED. THE PT REPORTED THAT HE/SHE COULD NOT VISIT THE ECP DUE TO WORK. THE PT SAID HIS/HER EYE WAS FINE. THE PT SAID THERE HAD BEEN A WHITE DOT ON THE CORNEA, ABOUT 1 MM IN SIZE, IT APPEARS TO HAVE BECOME SMALLER. THE PT WAS NOT WEARING LENSES WHEN CONTACTED. THE PT SAID HE/SHE HAD WORN THE LENSES FOR ABOUT 14 HOURS WHEN THE INITIAL SYMPTOM OCCURRED. THE PT SAID HE/SHE HAD KEPT APPLYING THE PRESCRIBED EYE DROPS SINCE THE FIRST VISIT TO THE ECP, BUT HE/SHE "DIDN'T APPLY IT OFTEN IN (B)(6)". THE PT IS SCHEDULED TO HAVE A F/U VISIT WITH THE ECP. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    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