BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISIGHT 1 DAY (OMAFILCON A)

    MDR report key: 22395329 · Received July 3, 2025

    Report

    Report Number
    3003981983-2025-00004
    Event Type
    Injury
    Date Received
    July 3, 2025
    Report Date
    July 3, 2025
    Manufacturer
    COOPERVISION MANUFACTURING LTD
    Product Code
    QIT
    UDI-DI
    96126LENS143LN
    PMA / PMN Number
    P180035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 HEALTHCARE PROVIDER (HCP), AND LIMITED INFORMATION HAS BEEN MADE AVAILABLE. ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT WAS TREATED FOR A CORNEAL ULCER. 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 LOCATION, SIZE OR SEVERITY OF THE REPORTED ULCER, UNKNOWN TREATMENT(S) AND UNKNOWN PATIENT RESOLUTION, AND THE POTENTIAL FOR SERIOUS OR PERMANENT INJURY, OR MEDICATION OR MEDICAL INTERVENTION NECESSARY TO PREVENT OR PRECLUDE SUCH OCCURRENCE, WITH SOME CORNEAL ULCER EVENTS. 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
    1176153 MISIGHT 1 DAY (OMAFILCON A) MISIGHT 1 DAY (OMAFILCON A) QIT COOPERVISION MANUFACTURING LTD UNKNOWN 96126LENS143LN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other