BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITI 1 DAY (SOMOFILCON A)

    MDR report key: 18364721 · Received December 20, 2023

    Report

    Report Number
    3009108089-2023-00005
    Event Type
    Injury
    Date Received
    December 20, 2023
    Report Date
    December 20, 2023
    Manufacturer
    COOPERVISION CL KFT
    Product Code
    MVN
    PMA / PMN Number
    K130331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (H3): 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. NOTE: AS IT IS UNKNOWN WHICH EYE (OS/OD) , OR IF BOTH EYES (OU) , WERE INVOLVED, PLEASE REFER TO LINKED MANUFACTURER REPORT CC543837 3009108089-2023-00006 FOR SECOND ASSOCIATED INCIDENT REPORT.

    Description of Event or Problem · 0

    THIS INCIDENT WAS REPORTED BY THE PATIENT'S LOCATION OF PURCHASE AS RELAYED BY THE END USER. IT WAS ALLEGED THAT THE PATIENT EXPERIENCED EYE INFECTION, THE PATIENT BELIEVES THIS IS DUE TO USING CONTACT LENSES THAT HAD BEEN KEPT IN EXTREME HEAT FOR AN EXTENDED PERIOD. 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
    2084770 CLARITI 1 DAY (SOMOFILCON A) CLARITI 1 DAY (SOMOFILCON A) MVN COOPERVISION CL KFT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other