BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA TORIC (ENFILCON A)

    MDR report key: 2361795 · Received November 29, 2011

    Report

    Report Number
    2640128-2011-00055
    Event Type
    Injury
    Date Received
    November 29, 2011
    Report Date
    October 28, 2011
    Manufacturer
    COOPER VISION CARIBBEAN, CORP.
    Product Code
    LPL
    PMA / PMN Number
    K071736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING REPORTED AS AN EYE INFECTION WITH UNCONFIRMED CASUAL RELATIONSHIP TO THE LENS. 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, AND UPDATE TO THIS REPORT WILL BE PROVIDED WITHIN ONE MONTH OF RECEIPT OF THE ADD'L INFO.

    Description of Event or Problem · 1

    PT REPORTS EYE INFECTION. FOLLOW UP WITH THE PT FOR MORE INFO HAS BEEN MADE, BUT NO REPLY FROM THE PT. THIS IS BEING FILED AS AN UNCONFIRMED EYE INFECTION.

    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 CARIBBEAN, CORP. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK