BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISIGHT 1 DAY (OMAFILCON A)

    MDR report key: 17127772 · Received June 14, 2023

    Report

    Report Number
    3003981983-2023-00004
    Event Type
    Injury
    Date Received
    June 14, 2023
    Date of Event
    May 24, 2023
    Report Date
    June 14, 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

    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 TO THE MANUFACTURER BY THE TREATING HEALTH CARE PROFESSIONAL. IT WAS REPORTED THE PATIENT EXPERIENCE REDNESS AND EYE PAIN AFTER SLEEPING WITH THE CONTACT LENSES. TWO DAYS LATER THE PATIENT WAS SEEN FOR MEDICAL TREATMENT AND DIAGNOSED WITH MICROBIAL KERATITIS IN THE RIGHT (OD) EYE. THE PATIENT WAS TREATED WITH MOXIFLOXACIN, INITIALLY PRESCRIBED HOURLY, DAY AND NIGHT, THEN TAPERED. PER THE TREATING FACILITY, THE PATIENT'S SYMPTOMS AND VISUAL ACUITIES HAVE IMPROVED BUT CURRENTLY UNRESOLVED AND TREATMENT IS ONGOING. THIS EVENT IS BEING REPORTED DUE TO THE INDICATION FROM THE TREATING PHYSICIAN OF MEDICATION OR MEDICAL INTERVENTION REQUIRED TO PREVENT OR PRECLUDE THE USER FROM PERMANENT INJURY OR IMPAIRMENT FROM THE CONDITION OF A MICROBIAL KERATITIS. 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
    1229505 MISIGHT 1 DAY (OMAFILCON A) MISIGHT 1 DAY (OMAFILCON A) QIT COOPERVISION MANUFACTURING LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female Other| R