BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA SPHERE (ENFILCON A)

    MDR report key: 2386252 · Received December 19, 2011

    Report

    Report Number
    9614392-2011-00086
    Event Type
    Injury
    Date Received
    December 19, 2011
    Report Date
    November 21, 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 ABRASION WITH CONJUNCTIVITIS AND CORNEAL SCARRING. 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

    PATIENT EXPERIENCED RED PAINFUL EYE. DR. DIAGNOSED WITH CORNEAL ABRASION, CONJUNCTIVITIS AND A CORNEAL SCAR THAT WAS NOTED IT DID NOT REDUCE VISUAL ACUITY. THE PATIENT WAS TREATED WITH VIGAMOX AND PRED FORTE. THIS IS BEING FILED AS CORNEAL ABRASION WITH CONJUNCTIVITIS AND CORNEAL SCARRING.

    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. 508205007806

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other