BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA SPHERE (ENFILCON A)

    MDR report key: 2403764 · Received January 5, 2012

    Report

    Report Number
    9614392-2011-00139
    Event Type
    Injury
    Date Received
    January 5, 2012
    Report Date
    December 5, 2011
    Manufacturer
    COOPERVISION MANUFACTURING, LTD.
    Product Code
    LPL
    PMA / PMN Number
    K071736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING FILED AS CORNEAL ULCER. METHOD: NO EXAMINATION OF DEVICE WAS PROVIDED WHICH COULD INDICATE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE INCIDENT. RESULTS: THERE IS NO DIRECT CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE MEDICAL DEVICE AND THE INCIDENT. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. SHOULD FURTHER INFO BE PROVIDED THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE PROVIDED WITHIN 30 DAYS OF RECEIPT OF THE ADD'L INFO.

    Description of Event or Problem · 1

    PT STATES THEY WERE DIAGNOSED WITH A CORNEAL ULCER IN THEIR OS. ATTEMPTS TO CONTACT THE PT FOR MORE INFO HAVE BEEN MADE WITH NO REPLY TO DATE. THIS IS BEING FILED AS CORNEAL ULCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAIRA SPHERE (ENFILCON A) LPL, SOFT CONTACT LENS, DAILY WEAR LPL COOPERVISION MANUFACTURING, LTD. 10433000013024

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other