BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A)

    MDR report key: 19726725 · Received July 11, 2024

    Report

    Report Number
    3009108089-2024-00003
    Event Type
    Injury
    Date Received
    July 11, 2024
    Report Date
    July 11, 2024
    Manufacturer
    COOPERVISION CL KFT
    Product Code
    MVN
    PMA / PMN Number
    K130331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE SAMPLE WAS RETURNED FOR MANUFACTURER ANALYSIS. A LOT NUMBER WAS PROVIDED FOR THE DEVICE ALLEGED TO BE INVOLVED IN THE INCIDENT. 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, COOPERVISION WILL COMPLETE ADDITIONAL INVESTIGATIONS AND SUBMIT A FOLLOW-UP REPORT AS APPROPRIATE. MANUFACTURER'S INVESTIGATION FOUND THIS DEVICE WAS MANUFACTURED AT A DIFFERENT FACILITY THAN ORIGINALLY REPORTED. MANUFACTURER REPORT NUMBER WAS CORRECTED FROM 9614392-2024-00022 TO 3009108089-2024-00003. G1 AND D3 UPDATED TO REFLECT THE CORRECT MANUFACTURER'S SITE AND MANUFACTURER'S REGISTRATION NUMBER 3009108089.

    Description of Event or Problem · 0

    THIS INCIDENT WAS REPORTED BY THE PATIENT TO THE MANUFACTURER. LIMITED INFORMATION HAS BEEN MADE AVAILABLE. IT WAS ALLEGED THAT THE PATIENT EXPERIENCED AN UNSPECIFIED EYE INFECTION IN THE RIGHT EYE (OD) WITH SYMPTOMS OF IRRITATION WHEN USING CONTACT LENSES. THE PATIENT ALSO REPORTED THAT THEY DID NOT SEEK MEDICAL ATTENTION FOR THEIR INFECTION AND THE ISSUE RESOLVED WITH THE USE OF OVER-THE-COUNTER SALINE EYE DROPS. THE PATIENT ALSO ALLEGES THAT THE CONTACT LENS STORAGE SOLUTION CONTAINS UNSPECIFIED FOREIGN FLOATING PARTICLE (S) AND THEY BELIEVE THIS IS WHAT CAUSING THE IRRITATION. GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION, INCLUDING RETURN OF REMAINING LENSES, WITHOUT SUCCESS. AS OF THE DATE OF THIS REPORT, ADDITIONAL INFORMATION IS UNKNOWN. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION DUE TO ALLEGATION OF OCULAR INFECTION OF UNKNOWN TYPE OR SEVERITY, LACK OF SUPPORTING MEDICAL INFORMATION AND POTENTIAL FOR SERIOUS INJURY RELATED TO OCULAR INFECTION. THIS ADVERSE EVENT WAS INITIALLY REPORTED ON 28 MAY 2024, UNDER MANUFACTURER REPORT NUMBER (B)(4), 9614392-2024-00022. ON 14 JUNE 2024, FURTHER NEW INFORMATION RECEIVED THAT NO ADVERSE EVENT OCCURRED UNDER THIS MANUFACTURER NUMBER (B)(4), 9614392-2024-00022. THIS REPORT WAS FILED UNDER THE WRONG MANUFACTURER NUMBER. THE CORRECT NUMBER SHOULD BE (B)(4), 3009108089-2024-00003. HENCE SUBMITTING UNDER THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2348883 CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A) CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A) MVN COOPERVISION CL KFT S0140865

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown Other