BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREQUENCY XCEL TORIC (METHAFILCON A)

    MDR report key: 2160467 · Received July 6, 2011

    Report

    Report Number
    9614392-2011-00036
    Event Type
    Injury
    Date Received
    July 6, 2011
    Report Date
    June 9, 2011
    Manufacturer
    COOPERVISION MANUFACTURING, LIMITED
    Product Code
    LPM
    PMA / PMN Number
    P850079
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS REPORTED AS A CORNEAL ULCER FROM A BUSINESS PARTNER IN THE (B)(6). 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: THERE IS NO DIRECT CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE MEDICAL DEVICE AND THE INCIDENT THE PT COMPLAINS OF. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. OPTICIAN FEELS THIS IS A RESULT OF THE PT OVER WEARING THE LENS. SHOULD FURTHER INFO BE PROVIDED THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE PROVIDED WITHIN ONE MONTH OF A RECEIPT OF THE ADD'L INFO.

    Description of Event or Problem · 1

    OPTICIANS OFFICE CALLED INTO COOPERVISION TO REPORT THEY HAD A PT WHO DEVELOPED A CORNEAL ULCER WHILE WEARING FREQUENCY XCEL TORIC. OFFICE ALSO STATED THE PT OVER WORE THE LENSES AND HAD POOR HYGIENE / HANDLING OF LENSES. OFFICE DOES NOT WANT TO FILL OUT MED INCIDENT REPORT FORM AND STATES THE PT IS NOW HAPPY AS THEY HAVE CHANGED HIM TO DAILY WEAR LENSES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other