BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITI 1 DAY (SOMOFILCON A)

    MDR report key: 21969143 · Received May 6, 2025

    Report

    Report Number
    3009108089-2025-00002
    Event Type
    Injury
    Date Received
    May 6, 2025
    Report Date
    May 6, 2025
    Manufacturer
    COOPERVISION CL KFT
    Product Code
    MVN
    PMA / PMN Number
    K130331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    THIS INCIDENT WAS REPORTED TO THE MANUFACTURER BY THE PATIENT, AND LIMITED INFORMATION HAS BEEN MADE AVAILABLE. ACCORDING TO THE DETAILS PROVIDED, THE PATIENT ALLEGED EXPERIENCING AN ALLERGIC REACTION, CORNEAL ABRASION, IRRITATION, AND AN UNSPECIFIED EYE INFECTION. GOOD FAITH EFFORTS HAVE BEEN MADE OBTAIN MORE INFORMATION WITHOUT SUCCESS. AS OF THE DATE OF THIS REPORT ADDITIONAL INFORMATION IS UNKNOWN. THIS EVENT IS BEING REPORTED WITH AN ABUNDANCE OF CAUTION DUE TO THE UNKNOWN NATURE OR SEVERITY OF THE ALLEGED INFECTION WITH A LACK OF MEDICAL INFORMATION, AND THE POTENTIAL FOR SERIOUS OR PERMANENT INJURY, OR MEDICATION TO PREVENT OR PRECLUDE THE OCCURRENCE OF SUCH EVENT, ASSOCIATED WITH SOME OCULAR INFECTIONS. 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
    99334 CLARITI 1 DAY (SOMOFILCON A) CLARITI 1 DAY (SOMOFILCON A) MVN COOPERVISION CL KFT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Unknown Other