BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYDAY (STENFILCON A)

    MDR report key: 17146455 · Received June 16, 2023

    Report

    Report Number
    2640128-2023-00004
    Event Type
    Injury
    Date Received
    June 16, 2023
    Date of Event
    April 20, 2023
    Report Date
    January 30, 2024
    Manufacturer
    COOPERVISION MANUFACTURING PUERTO RICO, LLC
    Product Code
    LPL
    PMA / PMN Number
    K131378
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NEW RELEVANT MEDICAL INFORMATION RECEIVED 16 JANUARY 2024. NO ROOT CAUSE COULD BE ESTABLISHED. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE INCIDENT IS UNCONFIRMED. MANUFACTURERS INCIDENT REPORT IS UPDATED TO REFLECT NEW DETAILS AND THE RESULTS OF DEVICE MANUFACTURING RECORDS REVIEW. REFER TO THE FOLLOWING FIELDS FOR UPDATED OR CORRECTED DATA: B2, B3, B4, B5, D4, G3, G6, H2, H4, H6, H10. WHILE THE INCIDENT ONLY OCCURRED IN THE LEFT EYE, IF IT'S UNKNOWN WHICH DEVICE WAS INVOLVED IN THE INCIDENT, PLEASE REFER TO MANUFACTURER REPORT, REFERENCE (B)(4) 2640128-2023-00005.

    Additional Manufacturer Narrative · 0

    (SEE H3) NO PRODUCT HAS BEEN MADE AVAILABLE FOR MANUFACTURER ANALYSIS. LOT NUMBER WAS PROVIDED FOR THE DEVICE ALLEGED TO BE INVOLVED IN THE INCIDENT. 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. WHILE THE INCIDENT ONLY OCCURRED IN THE LEFT EYE, IF IT UNKNOWN WHICH DEVICE WAS INVOLVED IN THE INCIDENT, PLEASE REFER TO MANUFACTURER REPORT, REFERENCE: (B)(4) 9614392-2023-00005.

    Description of Event or Problem · 0

    THIS INCIDENT WAS INITIALLY REPORTED UNDER 2640128-2023-00004 ON 16 JUNE 2023 AS CORNEAL ULCER WITH SYMPTOMS OF REDNESS, BURNING, AND IRRITATION OR PAIN IN THE LEFT (OS) EYE WITH A CORNEAL TRANSPLANT SCHEDULED FOR JUNE 2023. ADDITIONAL INFORMATION WAS RECEIVED ON 16 JAN 2024 AND INDICATES THAT THE PATIENT WAS BEING TREATED FOR THREE CORNEAL ULCERS/ABSCESSES IN THE LEFT (OS) EYE. THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO CLEAN THE WOUND(S) AND INJECT AN ANTIFUNGAL TREATMENT FOLLOWED BY A CORNEAL TRANSPLANT ON (B)(6) 2023. AS OF THE DATE OF THE INFORMATION SUPPLIED, LEGAL RECORDS COMPILED BETWEEN (B)(6) 2023, FILING DATED (B)(6) 2023, THE PATIENT ALLEGES A LOSS OF VISION IN THE AFFECTED EYE. NO ADDITIONAL MEDICAL INFORMATION WAS PROVIDED REGARDING FURTHER TREATMENTS. SHOULD FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPROPRIATE. WHILE THE INCIDENT ONLY OCCURRED IN THE LEFT EYE, IF IT'S UNKNOWN WHICH DEVICE WAS INVOLVED IN THE INCIDENT, PLEASE REFER TO MANUFACTURER REPORT, REFERENCE (B)(4) 2640128-2023-00005.

    Description of Event or Problem · 0

    THE INCIDENT WAS INITIALLY REPORTED BY THE PATIENT AS A CORNEAL ULCER WITH SYMPTOMS OF REDNESS, BURNING, AND IRRITATION OR PAIN IN THE LEFT (OS) EYE. ADDITIONAL DETAILS RECEIVED FROM THE INITIAL TREATING LOCATION, (B)(6) MONTPELLIER, INDICATE AN ULCER LOCATED IN THE NASAL AND CENTRAL REGION OF THE CORNEA. THE PATIENT WAS PRESCRIBED VANCOMYCIN AND FORTUM TO BE USED HOURLY AND INSTRUCTED TO DISCARD ALL CONTACT LENSES. THE PATIENT WAS TREATED AT THIS LOCATION IN MONTPELLIER ON (B)(6) WHILE ON HOLIDAY. PER INFORMATION FROM THE PATIENT'S MOTHER, RECEIVED (B)(6), TREATMENT CONTINUED IN (B)(6) WITH DR. (B)(6) AND INDICATED THE INCIDENT WAS NOT RESOLVING. THE PATIENT WAS SEEN FOR FURTHER TREATMENT AT THE (B)(6) HOSPITAL OPHTHALMOLOGY UNIT BEGINNING ON (B)(6) AND REMAINS UNDER TREATMENT. THE PATIENTS MOTHER STATES THE HOSPITAL IDENTIFIED A FUNGAL INFECTION AND THAT THE PATIENT WILL BE UNDERGOING A CORNEAL TRANSPLANT ON (B)(6). GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM ALL TREATING LOCATIONS WITHOUT SUCCESS. AS OF THE DATE OF THIS REPORT, ADDITIONAL INFORMATION IS UNKNOWN. WHILE THE INCIDENT ONLY OCCURRED IN THE LEFT EYE, IF IT UNKNOWN WHICH DEVICE WAS INVOLVED IN THE INCIDENT, PLEASE REFER TO MANUFACTURER REPORT, REFERENCE: (B)(4) 9614392-2023-00005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013728 MYDAY (STENFILCON A) MYDAY (STENFILCON A) LPL COOPERVISION MANUFACTURING PUERTO RICO, LLC 11322501503026

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention| O| H| S