BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISIGHT 1 DAY (OMAFILCON A)

    MDR report key: 16639532 · Received March 29, 2023

    Report

    Report Number
    3003981983-2023-02023
    Event Type
    Injury
    Date Received
    March 29, 2023
    Report Date
    March 29, 2023
    Manufacturer
    COOPERVISION MANUFACTURING LTD
    Product Code
    QIT
    PMA / PMN Number
    P180035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE SAMPLE WAS RETURNED FOR MANUFACTURER ANALYSIS. A LOT NUMBER WAS PROVIDED FOR THE DEVICE ALLEGED TO BE INVOLVED IN THE INCIDENT. LOT HISTORY, DEVICE HISTORY, STERILIZATION RECORDS, AND TREND REPORTING WERE REVIEWED. NO ISSUES OR NONCONFORMANCE'S WERE FOUND AND NO TRENDS WERE IDENTIFIED. 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 PATIENT'S PRESCRIBING OPTICIAN, WHO DID NOT SEE OR TREAT THE PATIENT DURING OR AFTER THE INCIDENT. THE DETAILS WERE RELAYED BY THE PATIENT, LIMITED INFORMATION HAS BEEN MADE AVAILABLE. IT IS REPORTED THAT THE PATIENT, IN ERROR, FELL ASLEEP WITH CONTACT LENSES INSTILLED AND WOKE WITH EYE PAIN. AFTER TWO DAYS OF SYMPTOMS THE PATIENT SOUGHT TREATMENT AT A HOSPITAL FACILITY AND WAS DIAGNOSED WITH A BACTERIAL INFECTION OF THE RIGHT EYE. IT IS INDICATED THAT THE PATIENT HAD TO HAVE MULTIPLE TYPES OF EYE DROPS, UNSPECIFIED, INSTILLED HOURLY FOR 24 HOURS AND SEVERAL MONTHS OF ONGOING TREATMENT, NO ADDITIONAL DETAILS PROVIDED. THE PRESCRIBING OPTICIAN INDICATES THAT THE INFECTION HAS RESOLVED BUT THE PATIENT IS LEFT WITH A CENTRAL CORNEAL OPACITY AND A PERMANENT REDUCTION OR LOSS OF VISION IN THE RIGHT EYE. THIS INCIDENT IS BEING REPORTED DUE TO THE INDICATION OF PERMANENT INJURY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPROPRIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304941 MISIGHT 1 DAY (OMAFILCON A) MISIGHT 1 DAY (OMAFILCON A) QIT COOPERVISION MANUFACTURING LTD 14945800251010

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female Other| S| R