BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISIGHT 1 DAY (OMAFILCON A)

    MDR report key: 17241487 · Received June 30, 2023

    Report

    Report Number
    3003981983-2023-00005
    Event Type
    Injury
    Date Received
    June 30, 2023
    Report Date
    June 30, 2023
    Manufacturer
    COOPERVISION MANUFACTURING LTD
    Product Code
    QIT
    PMA / PMN Number
    P180035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (SEE H3) 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 HEALTH CARE PROFESSIONAL, AND LIMITED INFORMATION HAS BEEN MADE AVAILABLE. IT IS REPORTED THAT THE PATIENT SOUGHT OUT MEDICAL ATTENTION AT A HOSPITAL WHERE THEY WERE DIAGNOSED MICROBIAL KERATITIS. INITIALLY, THE PATIENT EXPERIENCED VISION REDUCTION, BUT THEIR VISION HAS SINCE RETURNED. HOWEVER, A SMALL SCAR REMAINS OFF THE PATIENT'S VISUAL AXIS. GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION WITHOUT SUCCESS, AS OF THE DATE OF THIS REPORT ADDITIONAL INFORMATION IS UNKNOWN. THIS EVENT IS BEING REPORTED WITH AN ABUNDANCE OF CAUTION DUE TO THE UNKNOWN NATURE OR SEVERITY OF THE INCIDENT WITH A 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
    26165 MISIGHT 1 DAY (OMAFILCON A) MISIGHT 1 DAY (OMAFILCON A) QIT COOPERVISION MANUFACTURING LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| O