BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISIGHT 1 DAY (OMAFILCON A)

    MDR report key: 18846316 · Received March 6, 2024

    Report

    Report Number
    3003981983-2024-00001
    Event Type
    Injury
    Date Received
    March 6, 2024
    Date of Event
    February 1, 2024
    Report Date
    March 6, 2024
    Manufacturer
    COOPERVISION MANUFACTURING LTD
    Product Code
    QIT
    PMA / PMN Number
    P180035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. THE RELATIONSHIP BETWEEN THE COOPERVISION AND THE EVENT COULD NOT BE CONFIRMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS INCIDENT WAS REPORTED BY THE END USER'S LOCATION OF PURCHASE TO THE MANUFACTURER'S LOCAL CUSTOMER SERVICE OFFICE. INFORMATION PROVIDED INDICATES THAT THE PATIENT WAS SEEN FOR INITIAL FITTING AND FOLLOW-UP IN (B)(6) 2023. ON 28 DECEMBER 2023, AT FITTING FOLLOW-UP, AND REPORTED SYMPTOMS OF PHOTOPHOBIA. IT IS REPORTED THAT THE OCULAR SURFACE WAS HEALTHY BUT THE PATIENT WAS PRESCRIBED UNSPECIFIED ANTI-INFLAMMATORY MEDICINE AND ADVISED TO STOP WEARING THE CONTACT LENS. THE PATIENT WAS SEEN FOR MULTIPLE FOLLOW-UP VISITS WHERE CONTINUED SYMPTOMS WERE REPORTED AND CONTINUATION OF MEDICATION ADVISED. ON 1 FEBRUARY 2024, WHEN SYMPTOMS WERE STILL NOT IMPROVING, THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL, AND REPORTEDLY WAS DIAGNOSED WITH ACANTHAMOEBA KERATITIS AND UNDERWENT CORNEAL TRANSPLANT SURGERY. AS OF THE DATE OF THIS REPORT, TREATMENT IS ONGOING. 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 DIAGNOSIS OF ACANTHAMOEBA KERATITIS DIAGNOSIS WITH SURGICAL INTERVENTION, HOSPITALIZATION AND UNKNOWN PATIENT OUTCOME. 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
    1565463 MISIGHT 1 DAY (OMAFILCON A) MISIGHT 1 DAY (OMAFILCON A) QIT COOPERVISION MANUFACTURING LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Female Other| H| R