BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY SPHERE (COMFILCON A)

    MDR report key: 2499471 · Received March 19, 2012

    Report

    Report Number
    9614392-2012-00032
    Event Type
    Injury
    Date Received
    March 19, 2012
    Report Date
    February 20, 2012
    Manufacturer
    COOPERVISION MANUFACTURING, LTD.
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING REPORTED AS CORNEAL ULCER. THIS REPORT IS RELATED TO (B)(4) 9614392-2012-00033. 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 PATIENT COMPLAINS OF. CONCLUSIONS: NO CONCLUSIONS CAN BE DRAWN. SHOULD FURTHER INFORMATION BE PROVIDED THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE PROVIDED WITHIN ONE MONTH OF RECEIPT OF THE ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS RECEIVED AND TRANSLATED FROM (B)(6) AS CORNEAL ULCER. REPORTED AS GERMS IN THE EYE. OD: KERATITIS, DATE OF DIAGNOSIS: (B)(6) 2012 "CONJUNCTIVAL HYPEREMIA, ESPECIALLY SUPERIOR, CORNEAL ULCERATION AT 12 O'CLOCK, ANTERIOR CHAMBER: CLEAR, HYPEREMIA OF IRIS, MIOSIS CAUSED BY IRRITATION."

    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, LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other