BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A)

    MDR report key: 12097420 · Received June 30, 2021

    Report

    Report Number
    3009108089-2021-00003
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    July 6, 2020
    Report Date
    June 30, 2021
    Manufacturer
    COOPERVISION CL KFT
    Product Code
    MVN
    PMA / PMN Number
    K130331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE SAMPLE RETURNED FOR MANUFACTURER ANALYSIS. A LOT NUMBER WAS PROVIDED; LOT HISTORY, DEVICE HISTORY, STERILIZATION RECORDS AND TREND REPORTING WERE REVIEWED. NO ISSUES OR NONCONFORMANCE'S WERE FOUND AND NO TRENDS WERE IDENTIFIED, NO ROOT CAUSE COULD BE ESTABLISHED. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE INCIDENT IS UNCONFIRMED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE PATIENT THAT THEY HAD EXPERIENCED THREE INFECTIONS IN THE LEFT (OS) EYE OVER THE PAST YEAR WHILE USING THE DEVICE AND WAS PRESCRIBED NEOMYCIN AND LOTEPREDNOL TO TREAT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE TREATING EYE CARE PROVIDERS, PATIENTS PRIMARY EYE CARE PROVIDER AND THE OPHTHALMOLOGIST THEY WERE REFERRED TO. THE PATIENT WAS INITIALLY SEEN BY THEIR PRIMARY PROVIDER. THE FIRST INCIDENT WAS (B)(6) 2020, THE PATIENT HAD SYMPTOMS OF REDNESS, PAIN AND INTOLERANCE TO THE CONTACT LENSES. PATIENT PRESENTED WITH CORNEAL SCARRING (CORNEAL LEUKOMA OF THE SUPERIOR REGION, ENCROACHING NASALLY, TEMPORALLY, AND CENTRALLY. THE PATIENT WAS DIAGNOSED WITH CORNEAL LEUKOMA AND WAS PRESCRIBED MAXITROL (NEOMYCIN), THE INCIDENT RESOLVED. THE PATIENT WAS THEN SEEN IN (B)(6) 2021 AND (B)(6) 2021 FOR SIMILAR INCIDENTS WITH COMPLAINTS OF MUCUS, REDNESS, ITCHING, AND FOREIGN BODY SENSATION. IN (B)(6) 2021 THE PATIENT WAS DIAGNOSED WITH CORNEAL LEUKOMA, CONJUNCTIVAL HYPEREMIA, AND PUNCTATE KERATITIS AND PRESCRIBED MAXITROL AND REFERRED TO AN OPHTHALMOLOGIST DUE TO RECURRENCE. AT THE TIME OF REFERRAL, THE PATIENT HAD EXPERIENCED A REDUCTION IN VISION WHICH THE PRACTITIONER FEELS WILL BE PERMANENT. OPHTHALMOLOGIST INDICATES FINDINGS OF SUPERFICIAL STROMAL LEUKOMA (SUPERIOR) WITH NO NEOVASCULARIZATION AND SMALL PARACENTRAL LEUKOMA, NO EPITHELIAL DEFECT UPTAKE ON FLUORESCENCE INSTALLATION. LEUKOMA APPEARS LONG STANDING, NO ACTIVE INFECTION ON EXAM. PATIENT INSTRUCTED TO DISCONTINUE MAXITROL AND BEGIN USING INVELTYS (LOTEPREDNOL) AND FOLLOW-UP WITH PRIMARY AS SCHEDULED FOR FURTHER CARE. THIS INCIDENT IS BEING REPORTED DUE TO THE SUSPECTED PERMANENT DECREASE IN VISUAL ACUITY AND INTERVENTIONS OR MEDICATIONS REQUIRED TO TREAT THE CONDITION OF PERSISTENT EPITHELIAL DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988799 CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A) CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A) MVN COOPERVISION CL KFT R0096279

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| R