BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFMED BREATHABLES TORIC (ENFILCON A)

    MDR report key: 2259133 · Received September 19, 2011

    Report

    Report Number
    2640128-2011-00016
    Event Type
    Injury
    Date Received
    September 19, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 22, 2011
    Manufacturer
    COOPER VISION CARRIBBEAN CORP
    Product Code
    LFL
    PMA / PMN Number
    K071736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT WAS INITIALLY REPORTED BY AN EMAIL FROM THE PT'S MOTHER DIRECTLY TO COOPERVISION. METHOD: NO EXAMINATION OF DEVICE WERE PROVIDED WHICH COULD INDICATE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE INCIDENT. RESULTS: THERE IS NO CLEAR INDICATION THAT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. CONCLUSION: NO CONCLUSION CAN BE DRAWN. PTS ISSUES HAVE FULLY RESOLVED. THIS IS BEING REPORTED AS CORNEAL ULCERS. 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 IN A NEW PAIR OF SOFMED BREATHABLES TORIC (ENFILCON A) ON (B)(6) 2011. PT STARTED TO EXPERIENCE BLURRED VISION AND EYE PAIN. PT ALSO HAD SENSITIVITY TO LIGHT AND REDNESS IN BOTH EYES. PT WENT TO THE ER AND WAS DIAGNOSED WITH CORNEAL ULCERS AND POSSIBLE KERATITIS. PT WAS PRESCRIBED TOBRADEX AND ACETAMINOPHEN WITH CODEINE. AFTER FOLLOW-UP VISITS WITH EYE CARE PRACTITIONER, PTS OCULAR STATUS HAS RETURNED TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFMED BREATHABLES TORIC (ENFILCON A) LFL, SOFT CONTACT LENS, DAILY WEAR LFL COOPER VISION CARRIBBEAN CORP 5609500428060415

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other