BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA SPHERE (ENFILCON A)

    MDR report key: 2447462 · Received February 9, 2012

    Report

    Report Number
    9614392-2012-00007
    Event Type
    Injury
    Date Received
    February 9, 2012
    Report Date
    January 9, 2012
    Manufacturer
    COOPERVISION MANUFACTURING LIMITED
    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. CONCLUSION: CONCLUSION CAN BE DRAWN. SHOULD FURTHER INFORMATION BE PROVIDED THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE PROVIDED WITHIN 30 DAYS OF RECEIPT OF THE ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    THE PT REPORTS HE WAS TREATED FOR A CORNEAL ULCER IN THE O.S. FOLLOW UP WITH THE ECP FOR MORE INFORMATION NOTES THAT THE PT WAS DIAGNOSED WITH A CORNEAL ULCER AND WAS TREATED WITH CILOXAN. OPACITY SCARRING OF THE CORNEA THAT MAY OR MAY NOT IMPAIR VISION WAS NOTED. 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 LIMITED UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other