BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITI 1 DAY TORIC (SOMOFILCON A)

    MDR report key: 8573294 · Received May 2, 2019

    Report

    Report Number
    3009108089-2019-00004
    Event Type
    Injury
    Date Received
    May 2, 2019
    Report Date
    May 31, 2019
    Manufacturer
    COOPERVISION CL KFT
    Product Code
    MVN
    PMA / PMN Number
    K130331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AS NO USED LENSES INVOLVED IN THE INCIDENT WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, AND NOT ALL LENSES EVALUATED WERE OUTSIDE OF MANUFACTURER SPECIFICATION, IT IS UNCLEAR IF THE LENSES INVOLVED IN THE INCIDENT WERE OUTSIDE OF MANUFACTURERS SPECIFICATION. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE EVENT IS UNCONFIRMED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED EXPERIENCING IRRITATION IN THE LEFT (OS) EYE AFTER USING THE DEVICE AND SOUGHT MEDICAL TREATMENT. THE PATIENT WAS PRESCRIBED TOBRADEX. 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, LACK OF MEDICAL INFORMATION, AND UNKNOWN RESOLUTION. NEW MEDICAL INFORMATION RECEIVED FROM THE TREATING PHYSICIAN. THE PATIENT EXPERIENCED SYMPTOMS OF REDNESS AND EYE PAIN AND SOUGHT MEDICAL TREATMENT. THE PATIENT WAS DIAGNOSED WITH INFILTRATIVE KERATITIS AND PRESCRIBED LOTEMAX. THE INCIDENT HAS FULLY RESOLVED, AND THE PATIENT HAS RESUMED LENS USE. BASED ON THE INFORMATION FROM THE TREATING PHYSICIAN THIS INCIDENT DOES NOT MEET THE CRITERIA FOR A REPORTABLE ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED TO THE MANUFACTURER FOR DEVICE EVALUATION AND NO LOT NUMBER WAS REPORTED, THE MANUFACTURER IS UNABLE TO INVESTIGATE FURTHER. NO TRENDS WERE IDENTIFIED, AND NO ROOT CAUSE COULD BE ESTABLISHED. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE EVENT IS UNCONFIRMED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED EXPERIENCING IRRITATION IN THE LEFT (OS) EYE AFTER USING THE DEVICE AND SOUGHT MEDICAL TREATMENT. THE PATIENT WAS PRESCRIBED TOBRADEX. 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, LACK OF MEDICAL INFORMATION, AND UNKNOWN RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367038 CLARITI 1 DAY TORIC (SOMOFILCON A) CLARITI 1 DAY TORIC (SOMOFILCON A) MVN COOPERVISION CL KFT S0084894

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other