BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE TRUEYE NARAFILCON A

    MDR report key: 1892145 · Received October 26, 2010

    Report

    Report Number
    1033553-2010-00130
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    July 31, 2010
    Report Date
    October 26, 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

    METHOD - DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED. CONCLUSIONS - NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    OUR (B)(4) AFFILIATE REPORTS, ON (B)(6) 2010, A PT WHO WORE 1-DAY TRUEYE NARAFILCON A CONTACT LENSES (NARAFILCON A PRODUCT IS NOT MARKETED IN THE U.S.) REPORTED EXPERIENCING PAIN IN THE LEFT EYE (OS), BEING DIAGNOSED WITH CORNEAL STAINING OS AND INSTRUCTED TO D/C CONTACT LENS (CL) WEAR FOR 3 WEEKS. THE PT REPORTED HAVING RETURNED TO CL WEAR AT THE TIME THAT THE (B)(4) AFFILIATE WAS CONTACTED. ON 09/30/10, THE TREATING EYE CARE PROFESSIONAL (ECP) CONFIRMED THAT THE PT WAS INITIALLY SEEN AT THE EYE CLINIC ON (B)(6) 2010, DIAGNOSED WITH KERATITIS OS, INSTRUCTED TO D/C LENS WEAR AND TREATED WITH HYALEIN 0.1% AND CRAVIT DROPS. F/U (B)(6) 2010: SYMPTOM "DETERIORATED." BRONUCK DROPS WERE ALSO PRESCRIBED. ON (B)(6) 2010, THE PT WAS REFERRED TO THE (B)(6) MEDICAL CENTER. ON 10/05/10, THE ECP AT THE CLINIC PROVIDED ADDITIONAL INFO: ON (B)(6) 2010, THE PT PRESENTED WEARING CL WITH C/O "CORNEA BECAME CLOUDED" AND THE OS "FELT HEAVY." ECP NOTED KERATITIS (NO OPACITY) CAUSED BY CL WEAR AT THE "3 O'CLOCK DIRECTION" AND CILIARY INJECTION OS AND CONFIRMED DROPS PRESCRIBED. F/U (B)(6) 2010: PAIN AND OPACITY OS WORSENED VA WAS NOT MEASURED. F/U (B)(6) 2010: "OPACITY SPREAD" AND "TACHETIC" THE PT WAS REFERRED TO HOSPITAL. ECP REPORTED RECEIVING A LETTER FROM THE TREATING HOSPITAL ON (B)(6) 2010 INDICATING THAT ON (B)(6) 2010, THE PT WAS TREATED WITH GATIFLOXACIN AND FLUMETHOLON 0.1% DROPS FOR A (B)(6) CORNEAL PERIPHERAL INFILTRATION OS AND THAT THE SYMPTOM IMPROVED. THE PT RETURNED TO THE EYE CLINIC FOR F/U ON (B)(6) 2010, ECP NOTED KERATITIS IMPROVED, ONLY OPACITY REMAINED, VA NOT MEASURED CONTINUE FLUMETHOLON 0.1% DROPS. F/U (B)(6) 2010: "OPACITY STILL REMAINED BUT FADED." THE PT RESUMED CL WEAR; FLUMETHOLON 0.1% DROPS WERE CONTINUED. F/U (B)(6) 2010: "OPACITY SEEMED FADED." VA NOT MEASURED. THE PT DID NOT PRESENT FOR ANY ADDITIONAL F/U VISITS. THE LOT NUMBER OF THE PRODUCT IN QUESTION IS UNK. THE PRODUCT IN QUESTION HAS BEEN REQUESTED FOR RETURN FOR EVAL, BUT HAS NOT BEEN RECEIVED. 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. 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 50 YR Required Intervention