BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA TORIC (ENFILCON A)

    MDR report key: 2350364 · Received November 22, 2011

    Report

    Report Number
    2640128-2011-00049
    Event Type
    Injury
    Date Received
    November 22, 2011
    Report Date
    October 25, 2011
    Manufacturer
    COOPER VISION CARRIBBEAN CORP
    Product Code
    LPL
    PMA / PMN Number
    K071736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL COMPLAINT REPORTED BY THE PT'S MOTHER. METHOD - NO LOT INFO, NO LENSES NO EXAMINATION OF DEVICE WERE PROVIDED WHICH COULD INDICATE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. RESULTS - THERE IS NO CLEAR INDICATION THAT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. CONCLUSIONS - THERE IS NOT SUFFICIENT INFO PROVIDED TO DRAW A CONCLUSION AS TO WHETHER OR NOT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE PT'S COMPLAINT. NO CONCLUSION CAN BE DRAWN. 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'S MOTHER STATES THAT THE PT HAS HAD MULTIPLE LESIONS. THIS WAS NOT CONFIRMED THROUGH FOLLOW UP INVESTIGATION WITH THE ECPS, HOWEVER, THE PT WAS TREATED FOR (B)(6) AND GIVEN A PRESCRIPTION FOR ACYCLOVIR AND DILATING EYE DROPS. THE ECP NOTED FAINT STROMAL SCAR CENTRAL OD.

    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 1045400007004

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other