BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITI 1 DAY (SOMOFILCON A)

    MDR report key: 14804267 · Received June 24, 2022

    Report

    Report Number
    3009108089-2022-00001
    Event Type
    Injury
    Date Received
    June 24, 2022
    Report Date
    June 24, 2022
    Manufacturer
    COOPERVISION CL KFT
    Product Code
    MVN
    PMA / PMN Number
    K130331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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

    INCIDENT WAS REPORTED BY THE USER'S MOTHER, SHE BELIEVES HER CHILD HAD AN ALLERGIC REACTION TO THE CONTACT LENSES THAT RESULTED IN EMERGENCY MEDICAL TREATMENT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890045 CLARITI 1 DAY (SOMOFILCON A) CLARITI 1 DAY (SOMOFILCON A) MVN COOPERVISION CL KFT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other