BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISIGHT 1 DAY (OMAFILCON A)

    MDR report key: 16470570 · Received March 2, 2023

    Report

    Report Number
    3003981983-2023-00001
    Event Type
    Injury
    Date Received
    March 2, 2023
    Report Date
    March 2, 2023
    Manufacturer
    COOPERVISION MANUFACTURING LTD
    Product Code
    QIT
    PMA / PMN Number
    P180035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT HAS BEEN MADE AVAILABLE FOR MANUFACTURER ANALYSIS AND NO LOT NUMBER PROVIDED FOR MANUFACTURER INVESTIGATION. GIVEN THE LACK OF AVAILABLE DEVICE INFORMATION, THE MANUFACTURER IS UNABLE TO COMPLETE FURTHER INVESTIGATIONS AT THIS TIME AND NO ROOT CAUSE CAN BE ESTABLISHED. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE EVENT IS UNCONFIRMED. SHOULD FURTHER INFORMATION BECOME AVAILABLE, THE MANUFACTURER WILL COMPLETE FURTHER INVESTIGATIONS AS APPROPRIATE AND SUBMIT A FOLLOW-UP REPORT AS APPLICABLE.

    Description of Event or Problem · 0

    THIS INCIDENT WAS REPORTED BY THE OPTOMETRIST, TO THE MANUFACTURER. IT WAS ALLEGED THAT THE PATIENT EXPERIENCED KERATITIS OR EYE INFECTION, WHEN USING THE CONTACT LENS. GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION WITHOUT SUCCESS. AS OF THE DATE OF THIS REPORT, ADDITIONAL INFORMATION IS UNKNOWN. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION DUE TO THE LACK OF MEDICAL INFORMATION, UNCONFIRMED DIAGNOSIS, AND UNKNOWN PATIENT RESOLUTION. SHOULD FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPROPRIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1914456 MISIGHT 1 DAY (OMAFILCON A) MISIGHT 1 DAY (OMAFILCON A) QIT COOPERVISION MANUFACTURING LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female Other