BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITI 1 DAY TORIC (SOMOFILCON A)

    MDR report key: 6773157 · Received August 8, 2017

    Report

    Report Number
    3009108089-2017-00001
    Event Type
    Injury
    Date Received
    August 8, 2017
    Report Date
    August 8, 2017
    Manufacturer
    COOPERVISION CL KFT
    Product Code
    LPL
    PMA / PMN Number
    K130331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS CANNOT BE PERFORMED. NO LENSES WERE RETURNED FOR EVALUATION AND LOT NUMBER IS UNKNOWN. THE ASSOCIATION BETWEEN COOPERVISION LENSES AND THE EVENT IS UNCONFIRMED.

    Description of Event or Problem · 1

    THE EYE CARE PROVIDER ALLEGES THE PATIENT EXPERIENCED AN EYE INFECTION OF THE RIGHT (OD) EYE DUE TO THE CONTACT LENS MATERIAL. 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
    554904 CLARITI 1 DAY TORIC (SOMOFILCON A) CLARITI 1 DAY TORIC (SOMOFILCON A) LPL COOPERVISION CL KFT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other