BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITI 1 DAY (SOMOFILCON A)

    MDR report key: 19928582 · Received August 7, 2024

    Report

    Report Number
    3009108089-2024-00004
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    June 19, 2024
    Report Date
    August 7, 2024
    Manufacturer
    COOPERVISION CL KFT
    Product Code
    MVN
    PMA / PMN Number
    K130331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 TREATING EYE CARE PROFESSIONAL. IT WAS REPORTED THAT THE PATIENT SOUGHT MEDICAL TREATMENT ON (B)(6) 2024, AND WAS DIAGNOSED WITH A MID-PERIPHERAL CORNEAL ULCER WITH INFILTRATE IN THE RIGHT EYE (OD). THE PATIENT WAS TREATED WITH MOXIFLOXACIN AND MAXITROL EYE DROPS, TO BE INSTILLED EVERY SIX HOURS A DAY, AND TWO WEEKS OF LENS DISCONTINUATION. REPORT INDICATES THAT PATIENT HAD A FOLLOW-UP VISIT ON (B)(6) 2024. IT IS REPORTED THAT THE INCIDENT HAS RESOLVED AS OF (B)(6) 2024, WITHOUT PERMANENT INJURY OR VISION IMPACT, HOWEVER, MEDICAL INTERVENTION WAS REQUIRED TO PREVENT PERMANENT IMPAIRMENT OF EYE FUNCTION OR STRUCTURE. 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
    220479 CLARITI 1 DAY (SOMOFILCON A) CLARITI 1 DAY (SOMOFILCON A) MVN COOPERVISION CL KFT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Required Intervention| O