BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY SPHERE (COMFILCON A)

    MDR report key: 11157524 · Received January 12, 2021

    Report

    Report Number
    9614392-2021-00002
    Event Type
    Injury
    Date Received
    January 12, 2021
    Report Date
    January 12, 2021
    Manufacturer
    COOPERVISION MANUFACTURING, LTD.
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE SAMPLE RETURNED FOR MANUFACTURER ANALYSIS AND NO LOT NUMBER REPORTED, NO INVESTIGATION COULD BE COMPLETED, AND NO ROOT CAUSE ESTABLISHED. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE INCIDENT IS UNCONFIRMED.

    Description of Event or Problem · 1

    THE PATIENT WAS USING THE PRIVATE LABEL SWITCH PREMIER (BIOFINITY SPHERE) CONTACT LENSES AT THE TIME OF THE INCIDENT. IT IS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH BACTERIAL KERATITIS IN THE RIGHT (OD) EYE. THE PATIENT WAS TREATED FOR FOUR DAYS BY AN OUTPATIENT OPHTHALMOLOGIST THEN HOSPITALIZED IN THE EYE DEPARTMENT FOR 6 DAYS FOR A CORNEAL ULCER IN THE LOWER NASAL QUADRANT OF THE EYE. THE PATIENT WAS TREATED WITH A DUAL COMBINATION OF ANTIBIOTICS, BOTH LOCALLY AND INTRAVENOUSLY. THE PATIENT WAS DISCHARGED AND CONTINUES LOCAL TREATMENT WITH A DUAL COMBINATION OF ANTIBIOTICS; TREATMENT IS ONGOING AS OF (B)(6) 2020. THE CONTACT LENS FROM THE RIGHT EYE WAS CULTURED AND TESTED POSITIVE FOR THE PRESENCE OF THE PSEUDOMONAS AERUGINOSA BACTERIUM. THE RESIDUAL LENS CARE SOLUTION FROM THE BOTTLE WAS CULTURED AND NO BACTERIUM WAS PRESENT IN THE SAMPLE. NO LENSES HAVE BEEN RETURNED TO THE MANUFACTURER FOR DEVICE ANALYSIS AND NO LOT DETAILS HAVE BEEN MADE AVAILABLE. GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION WITHOUT SUCCESS, ADDITIONAL INFORMATION IS UNKNOWN. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION DUE TO UNCONFIRMED DIAGNOSIS, LACK OF MEDICAL INFORMATION, AND UNKNOWN RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49925 BIOFINITY SPHERE (COMFILCON A) BIOFINITY SPHERE (COMFILCON A) LPM COOPERVISION MANUFACTURING, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| R