BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A)

    MDR report key: 6822028 · Received August 25, 2017

    Report

    Report Number
    3009108089-2017-00005
    Event Type
    Injury
    Date Received
    August 25, 2017
    Report Date
    August 25, 2017
    Manufacturer
    COOPERVISION CL KFT
    Product Code
    MVN
    PMA / PMN Number
    K130331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATION BETWEEN COOPERVISION LENSES AND THE EVENT IS UNCONFIRMED.

    Description of Event or Problem · 1

    EYE CARE PROVIDER SENT A LETTER ALONG WITH PRODUCT RETURN TO THE MANUFACTURER ALLEGING THAT THE PATIENT WAS EXPERIENCING REOCCURRING EYE INFECTIONS WHILE USING THE PRODUCT. GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN ADDITIONAL MEDICAL INFORMATION WITHOUT SUCCESS, ADDITIONAL INFORMATION IS UNKNOWN. THIS EVENT IS BEING REPORTED DUE TO INCOMPLETE DIAGNOSIS, LACK OF MEDICAL INFORMATION, AND UNKNOWN RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600484 CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A) CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A) MVN COOPERVISION CL KFT R0048580

    Patients

    Seq Age Sex Outcome Treatment
    1 Other