BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA SPHERE (ENFILCON A)

    MDR report key: 2362955 · Received December 2, 2011

    Report

    Report Number
    9614392-2011-00077
    Event Type
    Injury
    Date Received
    December 2, 2011
    Report Date
    November 8, 2011
    Manufacturer
    COOPERVISION MANUFACTURING LIMITED
    Product Code
    LPL
    PMA / PMN Number
    K071736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING REPORTED AS CORNEAL ULCER. METHOD: NO EXAMINATION OF DEVICE WERE 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 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 TREATING ECP STATED THIS PATIENT HAD BILATERAL CORNEAL ULCERS AND TREATED THE PATIENT WITH TOBRADEX-S AND VIGGAMOX. THE PATIENTS MOTHER STATES THAT HER DAUGHTER WAS NOT SUPPOSED TO BE SLEEPING IN THE LENSES, BUT HAS SLEPT IN THE LENSES. ATTEMPTS TO CONTACT THE ECP FOR MORE INFORMATION HAVE BEEN MADE WITH NO REPLY TO DATE. THIS IS BEING REPORTED 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other