BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA TORIC (ENFILCON A)

    MDR report key: 2256993 · Received September 16, 2011

    Report

    Report Number
    2640128-2011-00013
    Event Type
    Injury
    Date Received
    September 16, 2011
    Report Date
    August 21, 2011
    Manufacturer
    COOPER VISION CARRIBBEAN CORP
    Product Code
    LPL
    PMA / PMN Number
    K071736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT WAS REPORTED BY EYE CARE PRACTITIONER DIRECTLY TO COOPERVISION SALES REP. METHOD: A LENS FROM THE SAME LOT AS THE ACTUAL LENS INVOLVED IN THE INCIDENT WAS EVALUATED. THE DEVICE WAS EXAMINED FOR VISUAL DEFECTS AND MEASURED FOR PARAMETERS. RESULTS: ATTEMPTS TO OBTAIN ADD'L INFO WERE UNSUCCESSFUL. COOPERVISION CANNOT CONFIRM THAT THERE WAS NO PERMANENT IMPAIRMENT OR PERMANENT DAMAGE. THERE IS NO CLEAR INDICATION THAT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. NO FAILURE WAS DETECTED AND THE PRODUCT WAS WITHIN SPEC. SHOULD FURTHER INFO BE PROVIDED THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE PROVIDED WITHIN ONE MONTH OF RECEIPT OF THE ADD'L INFO.

    Description of Event or Problem · 1

    EYE CARE PRACTITIONER (ECP) TRIAL FIT PT WITH AVAIRA TORIC (ENFILCON A) LENSES. PT WORE THE LENS FOR 6 WEEKS AND WAS FINE. WHEN PT PUT A NEW CONTACT LENS IN THE EYE BECAME IRRITATED. PT WENT TO ECP AND DESCRIBED THE EYES AS BEING "BUTCHERED" AND HAVING "SHREDDED CORNEAS." ATTEMPTS BY COOPERVISION TO RECEIVE ADD'L INFO REGARDING THIS INCIDENT HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAIRA TORIC (ENFILCON A) LPL, SOFT CONTACT LENS, DAILY WEAR LPL COOPER VISION CARRIBBEAN CORP 56545000386180315

    Patients

    Seq Age Sex Outcome Treatment
    1 Other