BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A)

    MDR report key: 8687802 · Received June 11, 2019

    Report

    Report Number
    3009108089-2019-00006
    Event Type
    Injury
    Date Received
    June 11, 2019
    Date of Event
    May 7, 2019
    Report Date
    July 11, 2019
    Manufacturer
    COOPERVISION CL KFT
    Product Code
    MVN
    PMA / PMN Number
    K130331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FOR UPDATED INFORMATION, SEE: (B4), (B6), (G7), (H2), (H4), (H6), (H10). AS THE USED LENS(ES) DIRECTLY INVOLVED IN THE INCIDENT WERE NOT RETURNED TO THE MANUFACTURER, IT IS UNCLEAR IF THE LENS(ES) INVOLVED WERE SUBJECT TO A DEVICE FAILURE OR MALFUNCTION. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE ADVERSE EVENT IS UNCONFIRMED.

    Additional Manufacturer Narrative · 1

    MANUFACTURERS INVESTIGATION IS ONGOING; LOT HISTORY, DEVICE HISTORY, STERILIZATION RECORDS AND TREND REPORTING WILL BE REVIEWED. A FOLLOW-UP REPORT WILL BE SUBMITTED ON COMPLETION.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED DIFFICULTY WITH THE RIGHT (OD) EYE AND SOUGHT MEDICAL TREATMENT THE FOLLOWING DAY. THE HEALTH CARE PROVIDER INDICATES THE PATIENT WAS DIAGNOSED WITH A NASAL PERIPHERAL INFECTIOUS CORNEAL ULCER AND WAS PRESCRIBED CIPROFLOXACIN OPHTHALMIC. THE HEALTHCARE PROVIDER STATES THE PATIENT IS COMPLIANT WITH HYGIENE AND WEAR AND REPLACEMENT SCHEDULE AS INSTRUCTED. THE PATIENT WAS SEEN FOR FOLLOW UP CARE AT ONE DAY AND FIVE DAYS AFTER THE INITIAL VISIT. BY DAY FIVE THE OPACITY HAD RE-EPITHELIZED, BUT THE PATIENT WAS INSTRUCTED TO CONTINUE WITH MEDICATION FOR AN ADDITIONAL THREE DAYS. THE INCIDENT HAS FULLY RESOLVED. THIS EVENT IS BEING REPORTED DUE TO THE HEALTH CARE PROVIDER'S INDICATION THAT MEDICAL ATTENTION AND/OR MEDICATION WERE REQUIRED TO PREVENT OR PRECLUDE IMPAIRMENT OF EYE FUNCTION OR STRUCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480582 CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A) CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A) MVN COOPERVISION CL KFT Y0063050

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| R