BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITI XR TORIC (FRP) (SOMOFILCON A)

    MDR report key: 8464443 · Received March 29, 2019

    Report

    Report Number
    9614392-2019-00007
    Event Type
    Injury
    Date Received
    March 29, 2019
    Date of Event
    February 17, 2019
    Report Date
    March 29, 2019
    Manufacturer
    COOPERVISION MANUFACTURING LTD
    Product Code
    LPL
    PMA / PMN Number
    K130342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 INCIDENT IS UNCONFIRMED.

    Description of Event or Problem · 1

    THE PATIENT STATES THAT UPON INSERTING A NEW CONTACT LENS IN THE RIGHT (OD) EYE ON (B)(6) 2019 SHE EXPERIENCED A FOREIGN BODY SENSATION BUT DID NOT REMOVE THE LENS AND SUBSEQUENTLY WHEN SKIING. THROUGHOUT THE DAY THE PATIENT BEGAN TO EXPERIENCE EYE PAIN AND DECREASED VISION. WHEN THE LENS WAS REMOVED IN THE AFTERNOON THE PATIENT EXPERIENCED PAIN AND A BURNING SENSATION AND VISION CONTINUED TO DECREASE. THE PATIENT WAS SEEN FOR EMERGENCY MEDICAL TREATMENT BY DR. (B)(6) AT (B)(6). THE PATIENT WAS DIAGNOSED WITH ACUTE GLAUCOMA AND ACUTE EYE VEIN THROMBOSIS, A NON-CONTACT LENS RELATED CONDITION, AND TAKEN BY AMBULANCE TO THE HOSPITAL FOR FURTHER TREATMENT. AT THE HOSPITAL THE PATIENT HAD MARKEDLY REDUCED VISION AND WAS DIAGNOSED WITH KERATITIS. SHE WAS PRESCRIBED TOBRADEX OINTMENT AND DROPS AND FLOXAL DROPS. THE PATIENT STATES SHE WAS TO USE EVERY HALF HOUR INITIALLY. THE PATIENT WAS SEEN FOR DAILY FOLLOW-UP AND WAS IMPROVING. ON (B)(6) THE MEDICATION WAS DECREASED TO EVERY TWO HOURS. SHE WAS ADVISED TO DISCONTINUE LENS USE AND ABSTAIN FROM CERTAIN ACTIVITIES THAT PRESUPPOSE A SPATIAL VISION, INCLUDING SKIING. GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN ADDITIONAL MEDICAL INFORMATION WITHOUT SUCCESS. ADDITIONAL INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257964 CLARITI XR TORIC (FRP) (SOMOFILCON A) CLARITI XR TORIC (FRP) (SOMOFILCON A) LPL COOPERVISION MANUFACTURING LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other