BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY (COMFILCON A)

    MDR report key: 2161888 · Received July 11, 2011

    Report

    Report Number
    9614392-2011-00040
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 16, 2011
    Manufacturer
    COOPERVISION MANUFACTURING, LTD.
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

    PATIENT AWOKE ON (B)(6) 2011 WITH SEVERE PAIN, REDNESS, PHOTOPHOBIA AND EPIPHORA. PATIENT ADMITS TO OCCASIONALLY ABUSING HER CONTACT LENSES SUCH AS OVER WEAR AND FALLING ASLEEP IN THEM. THE PATIENT CLAIMS SHE REMOVED THE LENSES THE NIGHT PRIOR TO HER SYMPTOMS. PATIENT WAS USING CLEAR CARE SOLUTION ON A DAILY WEAR BASIS. PATIENT WAS PRESCRIBED VIGAMOX AND REFRESH TEARS AND TEMPORARILY DISCONTINUED USE FOR ONE MONTH. THERE HAS BEEN NO REDUCTION IN VISUAL ACUITY AND PATIENT'S CURRENT OCULAR STATUS HAS IMPROVED. PATIENT IS BACK IN LENSES.

    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 24 YR Other