BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITI 1 DAY TORIC (SOMOFILCON A)

    MDR report key: 7968752 · Received October 16, 2018

    Report

    Report Number
    3009108089-2018-00005
    Event Type
    Injury
    Date Received
    October 16, 2018
    Date of Event
    September 7, 2018
    Report Date
    October 16, 2018
    Manufacturer
    COOPERVISION CL KFT
    Product Code
    MVN
    PMA / PMN Number
    K130331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS CANNOT BE PERFORMED AND ROOT CAUSE CANNOT BE IDENTIFIED. NO LENSES WERE RETURNED FOR EVALUATION. THE ASSOCIATION BETWEEN COOPERVISION LENSES AND THE EVENT IS UNCONFIRMED.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED SYMPTOMS OF DISCOMFORT AND POOR VISION, THE PATIENT DISCONTINUED LENS USE AND SOUGHT MEDICAL TREATMENT THE FOLLOWING DAY. THE PATIENT WAS DIAGNOSED WITH A CORNEAL ABRASION. AFTER A WEEK THE PATIENT SOUGHT ADDITIONAL MEDICAL TREATMENT AND WAS DIAGNOSED WITH A CORNEAL ULCER. THE PATIENT WAS PRESCRIBED PONSTAN (NSAID), CILOXAN (ANTIBIOTIC), GENDERMIN (ANTIBIOTIC), STROCAIN TABS (ANESTHETICS). PATIENT WAS SEEN FOR FOLLOW-UP CARE AFTER TWO DAYS AND "TENS" DAYS FROM DIAGNOSIS. IT IS REPORTED THAT THE PATIENT IS RECOVERING BUT HAS HAD A CHANGE IN VISUAL ACUITY, IT IS UNKNOWN IF THIS IS PERMANENT. GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN ADDITIONAL MEDICAL INFORMATION WITHOUT SUCCESS, ADDITIONAL INFORMATION IS UNKNOWN. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION DUE TO THE USE OF MEDICATION FOR TREATMENT AND CHANGES IN THE VISUAL ACUITY WITH UNKNOWN RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811933 CLARITI 1 DAY TORIC (SOMOFILCON A) CLARITI 1 DAY TORIC (SOMOFILCON A) MVN COOPERVISION CL KFT S0081045

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention