BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY SPHERE (COMFILCON A)

    MDR report key: 2499421 · Received March 20, 2012

    Report

    Report Number
    9614392-2012-00035
    Event Type
    Injury
    Date Received
    March 20, 2012
    Report Date
    February 21, 2012
    Manufacturer
    COOPERVISION MANUFACTURING LIMITED
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING REPORTED AS CORNEAL ULCER. METHOD: A REVIEW OF THE COMPLAINT HISTORY RECORD FOR THIS PRODUCT DID NOT ESTABLISH ANY CONCLUSIVE EVIDENCE THAT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. RESULTS: THERE IS NO DIRECT CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE MEDICAL DEVICE AND THE INCIDENT THE PT COMPLAINS OF. CONCLUSION: NO CONCLUSIONS CAN BE DRAWN. SHOULD FURTHER INFO BE PROVIDED THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE PROVIDED WITHIN ONE MONTH OF RECEIPT OF THE ADD'L INFO.

    Description of Event or Problem · 1

    THE PT WAS TREATED FOR PERIPHERAL CORNEAL ULCER AND PRESCRIBED VIGAMOX. THIS IS BEING REPORTED AS CORNEAL ULCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOFINITY SPHERE (COMFILCON A) LPM, SOFT CONTACT LENS, EXTENDED WEAR LPM COOPERVISION MANUFACTURING LIMITED 4848551532

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other