BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA SPHERE (ENFILCON A)

    MDR report key: 2393039 · Received December 22, 2011

    Report

    Report Number
    2640128-2011-00075
    Event Type
    Injury
    Date Received
    December 22, 2011
    Report Date
    November 25, 2011
    Manufacturer
    COOPER VISION CARRIBBEAN CORP
    Product Code
    LPL
    PMA / PMN Number
    K071736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING REPORTED AS IRITIS. METHOD - NO EXAMINATION OF DEVICE WERE PROVIDED WHICH COULD INDICATE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE INCIDENT. RESULTS - THERE IS NO DIRECT CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE MEDICAL DEVICE AND THE INCIDENT. CONCLUSION - NO CONCLUSION CAN BE DRAWN. SHOULD FURTHER INFO BE PROVIDED THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE PROVIDED WITHIN 30 DAYS OF RECEIPT OF THE ADD'L INFO.

    Description of Event or Problem · 1

    THE PT WAS SEEN FOR KERATITIS AND INFLAMMATION OF THE CORNEA. THE DOCTOR CONFIRMED THE PT HAS IRITIS IN BOTH EYES AND HAS BEEN RECEIVING TREATMENT FOR THE LAST FEW MONTHS. THE FLARE WAS MINIMAL OF 1+, BUT HAD RECURRENT EPISODES. THIS IS BEING FILED AS IRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAIRA SPHERE (ENFILCON A) LPL, SOFT CONTACT LENS, DAILY WEAR LPL COOPER VISION CARRIBBEAN CORP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other