BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY (COMFILCON A)

    MDR report key: 2161887 · Received July 11, 2011

    Report

    Report Number
    9614392-2011-00037
    Event Type
    Injury
    Date Received
    July 11, 2011
    Report Date
    June 21, 2011
    Manufacturer
    COOPERVISION MANUFACTURING, LTD.
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT WAS RECEIVED FROM EYE CARE PRACTITIONER TO COOPERVISION SALES REPRESENTATIVE IN (B)(4). METHOD: NO LOT INFORMATION, NO LENSES, NO DEVICE INFORMATION, NO EXAMINATION OF DEVICE WERE PROVIDED WHICH COULD INDICATE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE INCIDENT. RESULTS: THERE IS NO CLEAR INDICATION THAT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. 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 ONE MONTH OF RECEIPT OF THE ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    EYE CARE PRACTITIONER'S OFFICE IN (B)(4) INFORMED THEIR COOPERVISION SALES REPRESENTATIVE THAT THEY HAD A PATIENT WHO HAD BEEN DIAGNOSED WITH A CORNEAL ULCER WHILE WEARING BIOFINITY (COMFILCON A) CONTACT LENSES. THE PRACTICE STATED THIS INCIDENT HAPPENED A LONG TIME AGO AND THEY DID NOT HAVE ANY LOT DETAILS OR LENSES. THE PRACTICE FELT THE INCIDENT WAS ISOLATED AND DID NOT WISH TO RECEIVE OR FILL OUT THE MEDICAL INCIDENT REPORT FORM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other