BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISIGHT 1 DAY (OMAFILCON A)

    MDR report key: 20369372 · Received October 4, 2024

    Report

    Report Number
    3003981983-2024-00004
    Event Type
    Injury
    Date Received
    October 4, 2024
    Date of Event
    May 1, 2024
    Report Date
    January 30, 2025
    Manufacturer
    COOPERVISION MANUFACTURING LTD
    Product Code
    QIT
    PMA / PMN Number
    P180035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MEDICAL INFORMATION WAS RECEIVED, THIS NO LONGER MEETS THE CRITERIA OF A REPORTABLE ADVERSE EVENT. NO ROOT CAUSE COULD BE ESTABLISHED. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE INCIDENT IS UNCONFIRMED.

    Description of Event or Problem · 0

    THIS INCIDENT WAS REPORTED BY THE HEALTHCARE PROVIDER (HCP), AND LIMITED INFORMATION HAS BEEN MADE AVAILABLE. ACCORDING TO THE DETAILS PROVIDED, THE PATIENT WAS SEEN FOR AN UNSPECIFIED EYE INFECTION. 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 DIAGNOSIS OF AN EYE INFECTION WITH A LACK OF MEDICAL INFORMATION AND POTENTIAL FOR SERIOUS INJURY RELATED TO SOME OCULAR INFECTIONS. SHOULD FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS INCIDENT WAS INITIALLY REPORTED UNDER REFERENCE (B)(4) 3003981983-2024-00004 ON (B)(6), 2024, AS AN UNSPECIFIED EYE INFECTION. ADDITIONAL MEDICAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT EXPERIENCED OCULAR DISCOMFORT, REDNESS, AND PAIN. THE PATIENT WAS DIAGNOSED WITH A NON-INFECTIOUS PERIPHERAL CORNEAL ULCER AND WAS PRESCRIBED GATIFLOXACIN AND TOBRADEX. ACCORDING TO THE HEALTHCARE PROVIDER (HCP), THE INCIDENT FULLY RESOLVED AND DID NOT RESULT IN ANY PERMANENT INJURY, NOR MEDICAL INTERVENTIONS REQUIRED TO PREVENT OR PRECLUDE PERMANENT IMPAIRMENT OF EYE FUNCTION OR STRUCTURE. BASED ON THE ADDITIONAL MEDICAL INFORMATION, THE MANUFACTURER HAS DETERMINED THAT THIS NO LONGER MEETS THE CRITERIA FOR A REPORTABLE ADVERSE EVENT. ANY FURTHER MEDICAL INFORMATION RECEIVED AFTER THIS REPORT WILL BE REVIEWED, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267861 MISIGHT 1 DAY (OMAFILCON A) MISIGHT 1 DAY (OMAFILCON A) QIT COOPERVISION MANUFACTURING LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Other