BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA SPHERE (ENFILCON A)

    MDR report key: 2404260 · Received January 5, 2012

    Report

    Report Number
    1314956-2011-00024
    Event Type
    Injury
    Date Received
    January 5, 2012
    Report Date
    December 1, 2011
    Manufacturer
    COOPERVISION, INC.
    Product Code
    LPL
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: 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 REPORTS EYE INFECTION. ATTEMPTS TO CONTACT THE PT HAVE BEEN MADE WITH NO REPLY TO DATE. THIS IS BEING FILED AS AN UNCONFIRMED EYE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAIRA SPHERE (ENFILCON A) LPL, SOFT CONTACT LENS, DAILY WEAR LPL COOPERVISION, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other