BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE TRUEYE NARAFILCON A

    MDR report key: 1884095 · Received October 21, 2010

    Report

    Report Number
    1033553-2010-00124
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    August 4, 2010
    Report Date
    October 21, 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

    NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    INFO REC'D FROM OUR (B)(6) AFFILIATE. ON (B)(6) 2010, A CONTACT LENS SALES SHOP REP REPORTED THAT A PT WHO WORE 1-DAY TRUEYE NARAFILCON A CONTACT LENSES (NARAFILCON A PRODUCT IS NOT MARKETED IN THE U.S.) REPORTED BEING EXAMINED AT A CLINIC AND TREATED FOR STAINING IN THE LEFT EYE (OS). THE PT REPORTED EXPERIENCING SUDDEN PAIN AND CLOUDY VISION IN THE OS UPON INSERTION OF A CONTACT LENS (CL). ON 08/20/2010, A MEDICAL INTERVIEW WAS CONDUCTED WITH THE EYE CARE PROFESSIONAL (ECP) WHO INITIALLY TREATED THE PT. THE ECP CONFIRMED THAT THE PT PRESENTED (B)(6) 2010, DIAGNOSED WITH CORNEAL EROSION OS, POSSIBLE EKC, TREATED WITH VIGAMOX DROPS QID, TARIVID EYE OINTMENT AND THE OS WAS PATCHED. THE PT WAS ALSO INSTRUCTED TO D/C CL WEAR AND "REST." THE PT WAS REFERRED TO A SECOND CLINIC CLOSER TO THE PT'S HOME. ON 09/24/2010, THE ECP AT THE SECOND CLINIC PROVIDED ADD'L INFO. THE ECP CONFIRMED THAT THE PT PRESENTED ON (B)(6) 2010 HAVING ALREADY INITIALLY BEEN EXAMINED AND TREATED BY ANOTHER CLINIC. THE PT WAS PRESCRIBED CRAVIT DROPS, HYALEIN DROPS AND TARIVID EYE OINTMENT FOR THE OS. F/U (B)(6) 2010, THE ECP NOTED, "THE PT WAS TOLD THAT THE PT COULD OPEN OS IN TWO DAYS. THE PT HAD OPACITY IN THE CENTRAL CORNEA. THE PT WAS INSTRUCTED TO CONTINUE TO APPLY MEDICATIONS. THE PT'S VA WAS NOT MEASURED." THE PT DID NOT RETURN TO THE CLINIC FOR ADD'L F/U. ON (B)(6) 2010, THE PT RETURNED TO THE ECP WHO PRESCRIBED THE CONTACT LENSES. THE PT WAS ASYMPTOMATIC BUT STAINING WAS NOTED OS. THE PT WAS INSTRUCTED TO D/C CONTACT LENS WEAR FOR ONE WEEK; THE PT RESUMED CONTACT LENS WEAR ON (B)(6) 2010 WITHOUT FURTHER EVENT. DUE TO THE LENGTH OF TREATMENT, THIS EVENING IS BEING REPORTED WORST CASE. NO ADD'L INFO IS EXPECTED TO BE REC'D. ONE LENS CASE AND ONE SEALED BLISTER WERE RETURNED FOR EVAL. THE PARAMETERS OF THE LENSES WERE MEASURED AND A VISUAL INSPECTION WAS PERFORMED. THE LENSES MEET COMPANY STANDARDS FOR BASE CURVE, CENTER THICKNESS, AND DIAMETER. NO VISUAL ATTRIBUTES WERE OBSERVED. A LOT HISTORY WAS REQUESTED, 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. THERE WAS NOT ENOUGH SOLUTION TO MEASURE PH AND CONDUCTIVITY. THE LOT HISTORY REVIEW INDICATED THAT THIS LOT WAS MANUFACTURED UNDER NORMAL CONDITIONS. SUBSEQUENT TO THE RELEASE OF THIS LOT, IT WAS DISCOVERED THAT AN ISOLATED ISSUE IN ONE PORTION OF THE LENS RINSING PROCESS IMPACTED SOME PRODUCT FROM THE MFG LINE WHICH PRODUCED THIS LOT. AT THE TIME OF PRODUCT RELEASE, ALL DOCUMENTATION SHOWED THAT THIS LOT MET ALL RELEASE CRITERIA. BASED ON THE LIMITED INFO AVAILABLE, NO FURTHER INVESTIGATION CAN BE CONDUCTED AT THIS TIME. IF ADD'L INFO IS REC'D, 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 4922790704

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other