BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A)

    MDR report key: 8545331 · Received April 24, 2019

    Report

    Report Number
    3009108089-2019-00002
    Event Type
    Injury
    Date Received
    April 24, 2019
    Report Date
    April 24, 2019
    Manufacturer
    COOPERVISION CL KFT
    Product Code
    MVN
    PMA / PMN Number
    K130331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE EVENT IS UNCONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE EYE CARE PROVIDER THAT THE PATIENT EXPERIENCED ACUTE RED EYE, PAIN AND SORENESS, IRRITATION, AND A REDUCTION IN VISION EACH TIME SHE USED THE DEVICE. IT IS STATED THAT THE PATIENT WAS HOSPITALIZED AFTER WEARING THE LENSES. GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION WITHOUT SUCCESS, ADDITIONAL INFORMATION IS UNKNOWN. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION DUE TO INCOMPLETE DIAGNOSIS, ALLEGATION OF HOSPITALIZATION, LACK OF MEDICAL INFORMATION, AND UNKNOWN RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338397 CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A) CLARITI 1 DAY MULTFOCAL (SOMOFILCON A) MVN COOPERVISION CL KFT Y0062581

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O