BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITI 1 DAY (SOMOFILCON A)

    MDR report key: 21935730 · Received April 30, 2025

    Report

    Report Number
    3009108089-2025-00001
    Event Type
    Injury
    Date Received
    April 30, 2025
    Date of Event
    July 31, 2024
    Report Date
    May 22, 2025
    Manufacturer
    COOPERVISION CL KFT
    Product Code
    MVN
    PMA / PMN Number
    K130331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE SAMPLE RECEIVED AND ANALYSIS COMPLETE. FOR UPDATED DATA REFER TO THE FOLLOWING SECTIONS: (B4), (B6), (D9), (G2), (G3), (G6), (H2), (H3), (H6), (H11). MANUFACTURERS INVESTIGATION OF THE RETURNED DEVICE AND MANUFACTURING RECORDS FOUND NO FAILURES OR NONCONFORMANCES AND NO TRENDS WERE IDENTIFIED. NO ROOT CAUSE COULD BE ESTABLISHED, THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE INCIDENT IS UNCONFIRMED.

    Additional Manufacturer Narrative · 0

    NO DEVICE SAMPLE WAS RETURNED FOR ANALYSIS, MANUFACTURING RECORDS REVIEWED AND FOUND NO-ISSUES OR NON-CONFORMANCES. BASED ON THE AVAILABLE INFORMATION, NO ROOT CAUSE COULD BE ESTABLISHED. NO DIRECT OR DEFINITIVE CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE INCIDENT COULD BE CONFIRMED.

    Description of Event or Problem · 0

    THIS INCIDENT WAS REPORTED TO THE MANUFACTURERS LOCAL SALES OFFICE BY AN UNRELATED OPTOMETRIST, AS REPORTED BY THE PATIENT. THE PATIENT WAS LAST SEEN BY THE REPORTING PHYSICIAN IN 2017 FOR A ROUTINE EYE EXAM. THE PATIENT HAD PURCHASED CONTACT LENSES THROUGH THE CHAIN RETAILER'S SUBSCRIPTION PROGRAMME AND THIS STORE WAS THE PATIENT'S CLOSEST PHYSICAL LOCATION BUT WAS NOT THE TREATING PHYSICIAN AS RELATED TO THE EVENT. IT WAS ALLEGED THAT THE PATIENT CONTACTED THE RETAILER'S MAIN CUSTOMER SERVICE CENTRE ON (B)(6) 2024 TO REPORT THEY HAD EXPERIENCED A STINGING/BURNING SENSATION DURING USE OF A NEW LENS IN THE RIGHT (OD) EYE AND HAD DIFFICULTY OPENING THE EYE. THE PATIENT STATES THAT THEY HAVE NOT USED ANY EYE DROPS OR ANY OTHER TREATMENTS ON THE EYE BUT WAS ADVISED BY FAMILY TO USE A COLD-WATER BATH ON THE EYE. THE RETAILER MADE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, BUT THE PATIENT HAD REPORTEDLY GONE ON VACATION AND WAS UNRESPONSIVE. ON (B)(6) 2024, THE PATIENT ATTENDED THE LOCATION IN PERSON TO RETURN THE REMAINING CONTACT LENSES AND REPORTED THAT THEY HAVE BEEN SEEN BY ANOTHER OPTOMETRIST WHO DIAGNOSED A CORNEAL ULCER AND WOULD LIKE TO BE SEEN BY AN OPHTHALMOLOGIST AS THE PATIENT BELIEVES THERE ARE STILL UNSPECIFIED SORES ON THE EYE AND ADDITIONAL UNSPECIFIED OCULAR ISSUES. PATIENT HAS SELF-DISCONTINUED CONTACT LENS USE AND FEELS THAT THIS EVENT IS RELATED TO THE CONTACT LENS PACKAGING SOLUTION AND THE STINGING/BURNING SENSATION DURING USE. GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION WITHOUT SUCCESS. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION DUE TO UNKNOWN NATURE AND SEVERITY OF THE ALLEGED ULCER, UNCONFIRMED DIAGNOSIS, AND UNKNOWN RESOLUTION, AS WELL AS THE POTENTIAL FOR SERIOUS AND/OR PERMANENT INJURY ASSOCIATED WITH SOME OCULAR/CORNEAL ULCER EVENTS. SHOULD FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPROPRIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182234 CLARITI 1 DAY (SOMOFILCON A) ) MVN COOPERVISION CL KFT 16778706200007

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown Other