BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA TORIC (ENFILCON A)

    MDR report key: 2256994 · Received September 16, 2011

    Report

    Report Number
    2640128-2011-00012
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    June 16, 2011
    Report Date
    August 23, 2011
    Manufacturer
    COOPER VISION CARRIBBEAN CORP
    Product Code
    LPL
    PMA / PMN Number
    K071736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT WAS REPORTED BY EYE CARE PRACTITIONER DIRECTLY TO COOPERVISION. NO PRODUCT HAS BEEN RETURNED. METHOD: NO LOT INFO, NO LENSES, NO DEVICE INFO, NO EXAMINATION OF DEVICE WAS 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 THE PT COMPLAINS OF. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. THIS IS BEING REPORTED AS A REDUCTION OF VISUAL ACUITY LASTING LONGER THAN 7 DAYS WITH NO CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE MEDICAL DEVICE AND THE INCIDENT. 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

    PT PUT A NEW AVAIRA TORIC (ENFILCON A) CONTACT LENS IN THE EYE AND IT STARTED TO BECOME IRRITATED 45 MINUTES LATER. PT REMOVED THE LENS MID AFTERNOON BECAUSE OF POOR VISION ("MILKY") EYE STARTED TO HURT AND WATER. PT'S BEST CORRECTED VISUAL ACUITY DECREASED FOR LONGER THAN 7 DAYS AS A RESULT OF THE INCIDENT. PT WAS WEARING LENSES ON A DAILY WEAR BASIS. PT WAS REFIT INTO THE BIOFINITY TORIC AND AS OF (B)(6), 2011, THE PT'S OCULAR STATUS HAD FULLY RESOLVED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other