BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY SPHERE (COMFILCON A)

    MDR report key: 11157579 · Received January 12, 2021

    Report

    Report Number
    9614392-2021-00003
    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 TWO DAYS BY AN OUTPATIENT OPHTHALMOLOGIST AND HOSPITALIZED IN THE EYE DEPARTMENT FOR 5 DAYS WITH THE DIAGNOSIS OF WHOLE CORNEAL ULCER, ANTERIOR UVEITIS AND HYPOPYON IN THE ANTERIOR CHAMBER. THE PATIENT WAS TREATED WITH A DUAL COMBINATION OF ANTIBIOTICS, BOTH LOCALLY AND INTRAVENOUSLY. DURING TREATMENT THE PATIENT WAS CULTURED FOR ACANTHAMOEBA KERATITIS AND BROLENE WAS ADDED TO THE TREATMENT PLAN, THOUGH THE RESULTS RETURNED NEGATIVE. THE CONJUNCTIVAL SAC AND CORNEA OF THE RIGHT (OD) EYE WERE CULTURED AS WELL AS THE CONTACT LENS FROM THE HEALTHY LEFT EYE (OS) CULTURED AND TESTED POSITIVE FOR THE PRESENCE OF THE PSEUDOMONAS AERUGINOSA BACTERIUM; THE LENS FROM THE AFFECTED EYE WAS DISCARDED. THE RESIDUAL LENS CARE SOLUTION FROM THE BOTTLE WAS CULTURED AND NO BACTERIUM WAS PRESENT IN THE SAMPLE. THE PATIENT WAS TRANSFERRED TO RECEIVED FURTHER CARE DUE TO NON-IMPROVEMENT OF THE CONDITION WITH TREATMENT. IT IS ANTICIPATED THE PATIENT WILL BE LEFT WITH PERMANENT SCARING AND VISION REDUCTION OR LOSS. TREATMENT IS ONGOING AS OF (B)(6) 2020. 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
    50208 BIOFINITY SPHERE (COMFILCON A) BIOFINITY SPHERE (COMFILCON A) LPM COOPERVISION MANUFACTURING, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R