BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECT 1 DAY (SOMOFILCON A)

    MDR report key: 17896632 · Received October 9, 2023

    Report

    Report Number
    3009108089-2023-00004
    Event Type
    Injury
    Date Received
    October 9, 2023
    Date of Event
    September 24, 2023
    Report Date
    October 9, 2023
    Manufacturer
    COOPERVISION CL KFT
    Product Code
    MVN
    PMA / PMN Number
    K130331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3): 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 OPTICIAN (CONTACT LENS PRESCRIBING AND/OR RETAIL LOCATION) TO THE MANUFACTURER. IT WAS REPORTED THAT THE PATIENT WAS TREATED AT (B)(6) OPHTHALMOLOGY AND DIAGNOSED WITH A CORNEAL ULCER OF UNSPECIFIED LOCATION OR SEVERITY AND TREATED WITH UNSPECIFIED MEDICATION(S). 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 DIAGNOSIS, 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
    1923881 SELECT 1 DAY (SOMOFILCON A) SELECT 1 DAY (SOMOFILCON A) MVN COOPERVISION CL KFT AMO21899

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Other