BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE TRUEYE (NARAFILCON A)

    MDR report key: 2041165 · Received March 29, 2011

    Report

    Report Number
    1033553-2011-00024
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    October 16, 2010
    Report Date
    March 29, 2011
    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 EVALUATION WILL BE PERFORMED. CONCLUSIONS - NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A PATIENT CONTACTED OUR (B)(4) AFFILIATE ON (B)(6) 2010 TO REPORT EXPERIENCING A FOREIGN BODY SENSATION, INFLAMMATION AND ITCHING WHILE WEARING 1-DAY ACUVUE TRUEYE CONTACT LENSES (NARAFILCON A). NARAFILCON A CONTACT LENSES ARE NOT MARKETED IN THE US. THE PATIENT REPORTED DEVELOPING CONJUNCTIVITIS WHILE WEARING THE LENSES IN THE RIGHT EYE (OD). THERE WAS NO INFORMATION TO INDICATE THE PATIENT SUFFERED A SERIOUS ADVERSE EVENT. THE ECP'S OFFICE WAS CONTACTED ON (B)(6) 2011 AND OUR AFFILIATE WAS INSTRUCTED TO CONTACT THE ECP ON (B)(6) 2011. ON (B)(6) 2011, AN ASSOCIATE FROM OUR (B)(6) AFFILIATE CONTACTED THE ECP'S OFFICE AND RECEIVED THE FOLLOWING INFORMATION: ON (B)(6) 2010, THE PATIENT WAS HAVING ISSUES WITH DRY EYES WHILE WEARING HARD CONTACT LENSES. ON (B)(6) 2010, THE PATIENT WAS PRESCRIBED TEARBALANCE EYE DROPS. ON (B)(6) 2010, THE PATIENT REQUESTED TO BE TRIAL FITTED WITH 1-DAY TRUEYE CONTACT LENSES (CL) AND THE PATIENT PURCHASED PRODUCT ON (B)(6) 2010. ON (B)(6) 2010, THE PATIENT REPORTED A LENS FOR THE RIGHT EYE (OD) WAS CHIPPED. THE ECP NOTED THE PATIENT HAD CORNEAL STAINING OS THOUGH THERE WAS CAUSALITY NOTED BETWEEN THE CORNEAL STAINING AND THE 1-DAY ACUVUE TRUEYE CL. ON (B)(6) 2010, THE PATIENT RETURNED TO THE ECP'S OFFICE WITH OS CONJUNCTIVAL INJECTION AND DISCHARGE. THE INJECTION INVOLVED THE ENTIRE OS CONJUNCTIVA AND WAS ESPECIALLY INTENSE AT THE 5 TO 6 O'CLOCK POSITION. THE PATIENT WAS DIAGNOSED WITH A CORNEAL ULCER AND CONJUNCTIVITIS OS. THE CORNEAL ULCER WAS PERIPHERAL, LOCATED AT 5 TO 6 O'CLOCK, NEAR THE LIMBUS. THE PATIENT'S VA WAS NOT AFFECTED. THE CORNEAL ULCER WAS SUSPECTED TO BE INFECTIOUS, BUT THE CORNEA WAS NOT CULTURED. THE PATIENT WAS TREATED WITH CRAVIT AND BESTRON EYE DROPS, FREQUENCY WAS NOT PROVIDED AND THE PATIENT WAS INSTRUCTED TO DISCONTINUE CL WEAR AND RETURN TO CLINIC FOR FOLLOW-UP IN 3 DAYS. THE PATIENT DID NOT RETURN TO THE CLINIC UNTIL (B)(6) 2010, AT THAT TIME THE ECP NOTED THAT TREATMENT FOR THE OS WAS CONTINUED, CRAVIT AND ODOMEL, 4 TIMES A DAY. THE PATIENT WAS INSTRUCTED AGAIN TO DISCONTINUE CL WEAR. NO OBJECTIVE INFORMATION WAS PROVIDED. THE PATIENT RETURNED TO THE CLINIC ON (B)(6) 2010 AND THE CORNEAL ULCER AND CONJUNCTIVITIS WERE RESOLVED. THE ECP REFUSED TO PROVIDE ADDITIONAL INFORMATION. THE SUSPECT PRODUCT AND LOT NUMBER ARE NOT AVAILABLE. NO ADDITIONAL INFORMATION IS EXPECTED. 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 60 YR Other