BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY LENSES (COMFILCON A)

    MDR report key: 2100623 · Received May 17, 2011

    Report

    Report Number
    9614392-2011-00027
    Event Type
    Injury
    Date Received
    May 17, 2011
    Report Date
    April 20, 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 INITIALLY REPORTED BY A DISPENSING PRACTICE. NO PRODUCT HAS BEEN RETURNED AND NO WRITTEN DOCUMENTATION HAS BEEN RECEIVED. METHOD: NO LOT INFO, NO LENSES, NO DEVICE INFO, NO EXAM OF DEVICE WERE PROVIDED WHICH COULD INDICATE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE INCIDENT. RESULTS: ATTEMPTS TO OBTAIN ADDITIONAL INFO WERE UNSUCCESSFUL. WE CANNOT CONFIRM THAT THERE WAS NO PERMANENT IMPAIRMENT OR PERMANENT DAMAGE. CONCLUSIONS: THERE IS NOT SUFFICIENT INFO PROVIDED TO DRAW A CONCLUSION AS TO WETHER OR NOT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. 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 ADDITIONAL INFO.

    Description of Event or Problem · 1

    ON (B)(6), 2011, A DISPENSING PRACTICE INFORMED A COOPERVISION SALES REP THAT A PT DEVELOPED A CORNEAL ULCER WHILE WEARING BIOFINITY LENSES. PT WAS WEARING BIOFINITY (COMFILCON A) ON A CONTINUOUS WEAR BASIS FOR THE PAST SIX MONTHS AND WAS USING OPTIONS SOLUTIONS LENS CARE. NO FURTHER INFO HAS BEEN RECEIVED DESPITE SEVERAL REQUESTS TO THE ECP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other