BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA SPHERE (ENFILCON A)

    MDR report key: 2471874 · Received February 27, 2012

    Report

    Report Number
    9614392-2012-00016
    Event Type
    Injury
    Date Received
    February 27, 2012
    Report Date
    January 27, 2012
    Manufacturer
    COOPERVISION MFG 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 REPORTED AS CORNEAL SCAR. METHOD CODE: NO EXAMINATION OF DEVICE WERE PROVIDED WHICH COULD INDICATE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE INCIDENT. RESULTS CODE: THERE IS NO DIRECT CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE MEDICAL DEVICE AND THE INCIDENT. CONCLUSION CODE: 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 ADDITIONAL INFO.

    Description of Event or Problem · 1

    PT REPORTS SHE HAS DEVELOPED KERATITIS IN HER RIGHT EYE. STILL BEING TREATED. THE INVESTIGATIONAL RESPONSE FROM THE DOCTOR NOTES THAT THE PT HAD INFILTRATIVE KERATITIS AND HAS A HISTORY OF DRY EYE AND SLEEPING IN THE LENSES, OVER WEAR AND HAS CORNEAL SCARRING AS A RESULT. THIS IS BEING REPORTED AS CORNEAL SCAR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other