BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITI 1 DAY TORIC (SOMOFILCON A)

    MDR report key: 18371500 · Received December 21, 2023

    Report

    Report Number
    3009108089-2023-00007
    Event Type
    Injury
    Date Received
    December 21, 2023
    Report Date
    January 16, 2024
    Manufacturer
    COOPERVISION CL KFT
    Product Code
    MVN
    PMA / PMN Number
    K130331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE SAMPLE RETURNED FOR ANALYSIS, RECEIVED 1 JANUARY 2024 AND ANALYSIS COMPLETED ON 03 JANUARY 2024. MANUFACTURERS INCIDENT REPORT IS UPDATED TO REFLECT THE RESULTS OF DEVICE ANALYSIS AND INVESTIGATIONS. BASED ON MANUFACTURER ANALYSIS OF THE RETURNED DEVICE(S) AND INVESTIGATION, NO ROOT CAUSE COULD BE ESTABLISHED. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE EVENT IS UNCONFIRMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE ADDITIONAL INVESTIGATION WILL BE COMPLETED AND A FOLLOW-UP SUBMITTED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    (SEE H3) NO PRODUCT HAS BEEN MADE AVAILABLE FOR MANUFACTURER ANALYSIS. LOT NUMBER WAS PROVIDED FOR THE DEVICE ALLEGED TO BE INVOLVED IN THE INCIDENT. 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 HEALTH CARE PROVIDER TO THE MANUFACTURER, AND LIMITED INFORMATION HAS BEEN MADE AVAILABLE. IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH CONTACT LENS RELATED KERATITIS IN RIGHT EYE (OD) AND PHYSICIAN NOTED A PARACENTRAL INFERIOR SCAR OR OPACITY. 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 THE LACK OF MEDICAL INFORMATION, UNCONFIRMED SEVERITY OR TREATMENT, 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
    2050847 CLARITI 1 DAY TORIC (SOMOFILCON A) CLARITI 1 DAY TORIC (SOMOFILCON A) MVN COOPERVISION CL KFT T0160578

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Other