BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISIGHT1DAY (OMAFILCON A)

    MDR report key: 15006757 · Received July 13, 2022

    Report

    Report Number
    3003981983-2022-00001
    Event Type
    Injury
    Date Received
    July 13, 2022
    Report Date
    July 13, 2022
    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

    NO DEVICE SAMPLE WAS RETURNED FOR MANUFACTURER ANALYSIS. NO LOT NUMBER WAS PROVIDED FOR THE DEVICE ALLEGED TO BE INVOLVED IN THE INCIDENT. DUE TO THE LACK OF AVAILABLE DEVICE INFORMATION NO FURTHER INVESTIGATION CAN BE COMPLETED AT THIS TIME AND NO ROOT CAUSE COULD BE ESTABLISHED. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE INCIDENT IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH CORNEAL ULCER. THE INCIDENT WAS REPORTED TO THE MANUFACTURER THROUGH THE PROVIDER'S OFFICE. 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
    466015 MISIGHT1DAY (OMAFILCON A) MISIGHT1DAY (OMAFILCON A) QIT COOPERVISION MANUFACTURING LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Unknown Other