BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA SPHERE (ENFILCON A)

    MDR report key: 2452613 · Received February 10, 2012

    Report

    Report Number
    9614392-2012-00010
    Event Type
    Injury
    Date Received
    February 10, 2012
    Report Date
    January 11, 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 SCAR WITH INFILTRATIVE KERATITIS. 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 EXPERIENCED A RED PAINFUL EYE AND WAS DIAGNOSED WITH A CORNEAL SCAR IN OD AND SUSPECTED INFILTRATIVE KERATITIS. SHE WAS TREATED WITH ERYTHROMYCIN. THERE WAS NO REDUCTION OF ACUITY REPORTED. THIS IS BEING FILED AS CORNEAL SCAR WITH INFILTRATIVE KERATITIS.

    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 508205006313

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other