BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITI TORIC FRP (SOMOFILCON A)

    MDR report key: 6745108 · Received July 26, 2017

    Report

    Report Number
    3005405127-2017-00004
    Event Type
    Injury
    Date Received
    July 26, 2017
    Report Date
    November 8, 2017
    Manufacturer
    COOPERVISION CL LIMITED
    Product Code
    LPL
    PMA / PMN Number
    K130342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SEALED LENS RETURNED IN UNUSED CONDITION FOR MANUFACTURER EVALUATION. EVALUATION IN PROCESS, ADDITIONAL INFORMATION WILL BE PROVIDED VIA A FOLLOW UP REPORT ONCE AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE ASSOCIATION BETWEEN COOPERVISION LENSES AND THE EVENT IS UNCONFIRMED.

    Description of Event or Problem · 1

    PATIENT REPORTS DRYNESS AND SORENESS OF THE LEFT (OS) EYE AFTER USING LENSES. THE PATIENT ALLEGES AN EYE INFECTION THAT REQUIRED MEDICAL TREATMENT AND A CORNEAL ABRASION THAT REQUIRED EYE DROPS AND ANTIBIOTIC TREATMENT. GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN FURTHER MEDICAL INFORMATION WITHOUT SUCCESS. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION DUE TO 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
    525045 CLARITI TORIC FRP (SOMOFILCON A) CLARITI TORIC FRP (SOMOFILCON A) LPL COOPERVISION CL LIMITED A0102088

    Patients

    Seq Age Sex Outcome Treatment
    1 Other