BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA TORIC (ENFILCON A)

    MDR report key: 2223915 · Received August 19, 2011

    Report

    Report Number
    2640128-2011-00009
    Event Type
    Injury
    Date Received
    August 19, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 27, 2011
    Manufacturer
    COOPERVISION CARIBBEAN CORP.
    Product Code
    LPL
    PMA / PMN Number
    K071736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: TEN UNOPENED LENSES FROM THE SAME LOT AS THE ACTUAL LENS INVOLVED IN THE INCIDENT WERE EVALUATED. THE DEVICE WAS EXAMINED FOR VISUAL DEFECTS AND MEASURED FOR PARAMETERS. RESULTS: A REVIEW OF THE MFG RECORDS FOR THE DEVICE FOUND NOTHING TO INDICATE THAT THE DEVICE COULD HAVE CONTRIBUTED TO THE INCIDENT. CONCLUSIONS: NO FAILURE DETECTED AND PRODUCT WAS WITHIN SPEC. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PT WAS FIT INTO AVAIRA TORIC CONTACT LENSES USING TRIALS AND HAD PROBLEMS. WHEN PT INSERTED A FRESH PAIR OF LENSES FROM REVENUE BOXES THE PT'S LEFT EYE BECAME RED AND PAINFUL. PT WENT INTO EYE CARE PRACTITIONER'S OFFICE AND WAS TREATED FOR KERATITIS. ISSUE RESOLVED AND PT RESUMED CONTACT LENS WEAR. TEN DAYS LATER AFTER INSERTING A NEW PAIR OF LENSES ON (B)(6), 2011 SYMPTOMS RETURNED WITHIN 30 MINUTES. PT REMOVED LENSES AND CALLED EYE CARE PRACTITIONER. PT WAS ADVISED NOT TO WEAR CONTACT LENSES AND NOT TO PUT ANYTHING IN THE EYE. PT RETURNED TO THE EYE CARE PRACTITIONER'S OFFICE ON (B)(6), 2011 AND BY THAT TIME ALL SYMPTOMS HAD RESOLVED. PT WAS GIVEN A NEW TRIAL LENS FOR THE LEFT EYE WITH A DIFFERENT LOT NUMBER AND PT HAD NO PROBLEMS. DOCTOR FOLLOWED-UP ONE WEEK LATER AND PT WAS STILL WEARING TRIAL LENSES COMFORTABLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAIRA TORIC (ENFILCON A) LPL, SOFT CONTACT LENS, DAILY WEAR LPL COOPERVISION CARIBBEAN CORP. 561850043720

    Patients

    Seq Age Sex Outcome Treatment
    1 Other