BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITI MULTIFOCAL FRP (SOMOFILCON A)

    MDR report key: 6490222 · Received April 13, 2017

    Report

    Report Number
    3005405127-2017-00002
    Event Type
    Injury
    Date Received
    April 13, 2017
    Date of Event
    October 6, 2015
    Report Date
    April 13, 2017
    Manufacturer
    COOPERVISION CL LIMITED
    Product Code
    LPL
    PMA / PMN Number
    K130342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT ALLEGES WATERING AND SWELLING WITH DECREASED VISION IN THE RIGHT (OS). PATIENT ALLEGES EMERGENCY MEDICAL ATTENTION WAS SOUGHT THE DAY AFTER SYMPTOMS BEGAN AND SHE WAS DIAGNOSED WITH A BACTERIAL INFECTION OF THE RIGHT (OS) EYE. GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN MEDICAL INFORMATION WITHOUT SUCCESS. THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION DUE THE ALLEGATIONS OF AN EYE INFECTION, INCOMPLETE DIAGNOSIS, LACK OF MEDICAL INFORMATION, AND UNKNOWN RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274074 CLARITI MULTIFOCAL FRP (SOMOFILCON A) CLARITI MULTIFOCAL FRP (SOMOFILCON A) LPL COOPERVISION CL LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other