BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A)

    MDR report key: 16983669 · Received May 23, 2023

    Report

    Report Number
    3009108089-2023-00002
    Event Type
    Injury
    Date Received
    May 23, 2023
    Report Date
    May 23, 2023
    Manufacturer
    COOPERVISION CL KFT
    Product Code
    MVN
    PMA / PMN Number
    K130331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT HAS BEEN MADE AVAILABLE FOR MANUFACTURER ANALYSIS. LOT NUMBER WAS PROVIDED FOR THE DEVICE ALLEGED TO BE INVOLVED IN THE INCIDENT. 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. AS THE CONSUMER ALLEGES INFECTION OF BOTH EYE AND USES A DIFFERENT DEVICE IN EACH EYE, REFER TO MANUFACTURER REPORT (B)(6) 3009108089-2023-00001 FOR THE LINKED INCIDENT REPORT.

    Description of Event or Problem · 0

    THIS INCIDENT WAS RECEIVED BY VIA DISTRIBUTOR, (B)(4), CONTAINING LIMITED INFORMATION. THE REPORT INDICATES A COMPLAINT WAS MADE BY A CONSUMER WHO ALLEGES TO HAVE BEEN DIAGNOSED WITH A BACTERIAL EYE INFECTION. NO FURTHER DETAILS WERE PROVIDED. CONTACT DETAILS AND AUTHORIZATION TO CONTACT THE CONSUMER PROVIDED BY THE DISTRIBUTOR. GOOD FAITH EFFORTS HAVE BEEN MADE OBTAIN MORE INFORMATION FROM THE CONSUMER WITHOUT RESPONSE. 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 INCIDENT WITH A LACK OF MEDICAL INFORMATION, AND POTENTIAL FOR PERMANENT INJURY. 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
    218505 CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A) CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A) MVN COOPERVISION CL KFT AA111474

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other