BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITI 1 DAY (SOMOFILCON A)

    MDR report key: 18456841 · Received January 5, 2024

    Report

    Report Number
    3009108089-2024-00001
    Event Type
    Injury
    Date Received
    January 5, 2024
    Date of Event
    December 21, 2023
    Report Date
    January 5, 2024
    Manufacturer
    COOPERVISION CL KFT
    Product Code
    MVN
    PMA / PMN Number
    K130331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (SEE H3) 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 BY THE PATIENT TO THE MANUFACTURER AND LIMITED INFORMATION HAS BEEN MADE AVAILABLE. THE PATIENT REPORTED EXPERIENCING A SHARP PAIN IMMEDIATELY AFTER INSERTING THE CONTACT LENS. UPON REMOVING THE LENS, THEY NOTED INFLAMMATION AND ONGOING PAIN. SUBSEQUENTLY, THE PATIENT SOUGHT MEDICAL ATTENTION AT A HOSPITAL WHERE THEY STATE THEY WERE DIAGNOSED WITH KERATITIS (CORNEAL INFECTION) AND PRESCRIBED AN UNSPECIFIED ANTIBIOTIC FOR ONE WEEK. 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 REPORTED DIAGNOSIS OF KERATITIS/INFECTION OF UNKNOWN SEVERITY, LACK OF SUPPORTING MEDICAL INFORMATION, 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
    601316 CLARITI 1 DAY (SOMOFILCON A) CLARITI 1 DAY (SOMOFILCON A) MVN COOPERVISION CL KFT AC118843

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Unknown Other