BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY TORIC (COMFILCON A)

    MDR report key: 1961392 · Received January 10, 2011

    Report

    Report Number
    9614392-2011-00002
    Event Type
    Injury
    Date Received
    January 10, 2011
    Report Date
    December 13, 2010
    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

    METHOD: NO LOT INFO, NO LENSES, NO DEVICE INFO, NO EXAMINATION OF DEVICE WERE PROVIDED WHICH COULD INDICATE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE INCIDENT. RESULTS: WE ARE REPORTING THIS BECAUSE WE CANNOT CONFIRM THAT THERE WAS NO PERMANENT IMPAIRMENT OR PERMANENT DAMAGE. THERE IS NO CLEAR INDICATION THAT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. CONCLUSIONS: NO CONCLUSION 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

    ON (B)(6), ECP REPORTED A CLASSIC CLPU. RAISED AREA IN THE PERIPHERY NEAR THE LIMBUS, WITH A NEARLY WHITE EYED PRESENTATION. NO CLINICAL DATA IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other