BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY SPHERE (COMFILCON A)

    MDR report key: 9433124 · Received December 6, 2019

    Report

    Report Number
    9614392-2019-00034
    Event Type
    Injury
    Date Received
    December 6, 2019
    Date of Event
    August 6, 2019
    Report Date
    December 6, 2019
    Manufacturer
    COOPERVISION MANUFACTURING, LTD.
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED TO THE MANUFACTURER FOR DEVICE EVALUATION AND NO LOT NUMBER PROVIDED. THE MANUFACTURER IS UNABLE TO INVESTIGATE FURTHER AT THIS TIME. SHOULD FURTHER INFORMATION BECOME AVAILABLE, COOPERVISION WILL SUBMIT A FOLLOW-UP REPORT TO MHRA. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE INCIDENT IS UNCONFIRMED. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE EVENT IS UNCONFIRMED.

    Description of Event or Problem · 1

    THE PATIENT WAS SEEN FOR A REGULAR CHECKUP, THE PATIENT WAS ASYMPTOMATIC, HOWEVER, AND TWENTY TO THIRTY OPACITY, LIKE EPIDEMIC KERATOCONJUNCTIVITIS (EKC) WERE OBSERVED THROUGHOUT THE CORNEA IN BOTH EYES (OU). THE PATIENT WAS INSTRUCTED TO DISCONTINUE LENS USE PRESCRIBED A STEROID AND ANTIBIOTIC, MEDICATION UNSPECIFIED. THE PATIENT RETURNED TO THE CLINIC ONE MONTH LATER, IN OCTOBER, AND THE OPACITY WERE REDUCED, AND PATIENT WAS CLEARED TO RESUME LENS USE AFTER TWO ADDITIONAL WEEKS. ONE MONTH LATER, IN NOVEMBER, THE PATIENT WAS SEEN FOR A REGULAR CHECK-UP AND WAS AGAIN ASYMPTOMATIC BUT AGAIN TWENTY TO THIRTY OPACITY WERE OBSERVED THROUGHOUT THE CORNEA IN BOTH EYES (OU). PATIENT WAS INSTRUCTED TO DISCONTINUE LENS USE AND WAS PRESCRIBED A STEROID AND ANTIBIOTIC, MEDICATION UNSPECIFIED. AT THE TIME OF THE REPORT, THE INCIDENT WAS UNRESOLVED. IT IS UNCLEAR IF THE MEDICATIONS WERE PRESCRIBED TO PREVENT OR PRECLUDE A PERMANENT INJURY. GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION WITHOUT SUCCESS, ADDITIONAL INFORMATION IS UNKNOWN. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION DUE TO UNCLEAR DIAGNOSIS, LACK OF MEDICAL INFORMATION, AND UNKNOWN RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224596 BIOFINITY SPHERE (COMFILCON A) BIOFINITY SPHERE (COMFILCON A) LPM COOPERVISION MANUFACTURING, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other