BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY (COMFILCON A)

    MDR report key: 2041191 · Received March 29, 2011

    Report

    Report Number
    9614392-2011-00010
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    May 1, 2010
    Report Date
    March 3, 2011
    Manufacturer
    COOPERVISION MANUFACTURING LIMITED
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT WAS REPORTED BY PT'S O.D. IT IS REPORTED AS CORNEAL ULCERS IN BOTH EYES. NO WRITTEN DOCUMENTATION HAS BEEN REC'D DESPITE SEVERAL REQUESTS TO THE ECP. NO PRODUCT HAS BEEN RETURNED. 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 DIRECT CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE MEDICAL DEVICE AND THE INCIDENT THE PT COMPLAINS OF. CONCLUSION: NO CONCLUSION CAN BE DRAWN. THIS IS BEING REPORTED AS REOCCURRING CORNEAL ULCERS WITH NO DIRECT CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE MEDICAL DEVICE AND THE INCIDENT. 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

    THE PT HAS BEEN SUFFERING REOCCURRING ULCERS IN BOTH EYES SINCE THE PT STARTED WEARING BIOFINITY LENSES FROM MAY, 2010. THE PT WORE THE LENS FOR TWO WEEKS AND DEVELOPED AN ULCER WHICH THEY WERE TREATED FOR WITH MEDICATION. UPON RETURNING TO LENS WEAR, THE PT CONTRACTED ANOTHER ULCER. THE DOCTORS OFFICE STATED THAT THEY WOULD NOT COMPLETE THE MEDICAL QUESTIONNAIRE AS THEY DO NOT FEEL THE ULCERS ARE LENS RELATED. THEY BELIEVE THE PT JUST CAN'T WEAR THE LENS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other