BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISIGHT 1 DAY (OMAFILCON A)

    MDR report key: 23727122 · Received December 5, 2025

    Report

    Report Number
    3003981983-2025-00006
    Event Type
    Injury
    Date Received
    December 5, 2025
    Report Date
    December 5, 2025
    Manufacturer
    COOPERVISION MANUFACTURING LTD
    Product Code
    QIT
    UDI-DI
    96126LENS143LN
    PMA / PMN Number
    P180035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE SAMPLE RETURNED FOR MANUFACTURER ANALYSIS AND NO LOT NUMBER REPORTED, NO INVESTIGATION COULD BE COMPLETED. GIVEN THE LACK OF AVAILABLE EVENT AND DEVICE DETAILS, NO ROOT CAUSE ESTABLISHED. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE INCIDENT IS UNCONFIRMED.

    Description of Event or Problem · 0

    THIS INCIDENT WAS REPORTED BY THE PATIENT'S CONTACT LENS PRESCRIBER AND RETAILER MAIN OFFICE, AS RELAYED BY THE PATIENT. IT WAS REPORTED THAT THE PATIENT RECEIVED A 5-PACK PER EYE OF DIAGNOSTIC CONTACT LENSES ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT ALLEGED THAT CONTACT LENSES DISPENSED FOR THE LEFT (OS) EYE WERE EXPIRED AND THAT THE USE OF THE LENSES CAUSED AN UNSPECIFIED EYE INFECTION WHICH LED TO A CORNEAL ULCER AND POOR VISUAL ACUITY. IT IS REPORTED THAT AS OF THE DATE OF THE REPORT, THE INCIDENT HAS RESOLVED. WHILE THE REPORTER INDICATES THAT THE EVENT HAS RESOLVED, IT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION DUE TO ALLEGATION OF OCULAR INFECTION AND CORNEAL ULCER OF UNKNOWN TYPE, LOCATION, SIZE, OR SEVERITY, WITH LACK OF ASSOCIATED MEDICAL INFORMATION AND THE POTENTIAL FOR SERIOUS OR PERMANENT INJURY, OR THE NECESSITY OF MEDICAL INTERVENTION OR MEDICATION TO PREVENT OR PRECLUDE SUCH OCCURRENCE, WHICH CAN BE ASSOCIATED WITH SOME OCULAR INFECTION AND CORNEAL ULCER EVENTS. SHOULD FURTHER INFORMATION BECOME AVAILABLE, THE MANUFACTURER WILL COMPLETE FURTHER INVESTIGATIONS AS APPROPRIATE AND SUBMIT A FOLLOW-UP REPORT AS APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2848587 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