BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENICON ASRB (ASMOFILCONA)

    MDR report key: 21465564 · Received February 25, 2025

    Report

    Report Number
    1000188353-2025-00004
    Event Type
    Injury
    Date Received
    February 25, 2025
    Date of Event
    January 21, 2025
    Report Date
    February 26, 2025
    Manufacturer
    MENICON CO., LTD.
    Product Code
    LPL
    PMA / PMN Number
    K180004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS EVENT OCCURRED IN JAPAN. THE PATIENT WORE 1 MONTH MELSME TORIC, WHICH IS A SIMILAR DEVICE OF MENICON ASRB (ASMOFILCON A) SILICONE HYDROGEL SOFT CONTACT LENS (K180004). ON (B)(6) 2025, THE PATIENT (PT) WAS SEEN BY AN OPHTHALMOLOGIST AND DIAGNOSED WITH A CORNEAL ULCER IN HER LEFT EYE. IN ADDITION, THE AFFECTED AREA OF THE CORNEA SHOWED OPACITY, BUT HER VISION WAS NOT AFFECTED. PT WAS INSTRUCTED TO STOP WEARING LENSES, AND PRESCRIBED GATIFLOXACIN OPHTHALMIC SOLUTION (6 TIMES A DAY) AND BESTRON FOR OPHTHALMIC (6 TIMES A DAY). ON (B)(6) 2025, PT RETURNED TO FOLLOW-UP AND WAS INSTRUCTED TO USE OPHTHALMIC SOLUTIONS 4 TIMES A DAY (OPHTHALMIC SOLUTIONS WERE UNCHANGED FROM ABOVE). ON (B)(6) 2025, THE ANTERIOR SEGMENT FINDINGS IN HER LEFT EYE DISAPPEARED AND PT WAS DIAGNOSED RECOVERED AND ALLOWED TO RESUME WEARING LENSES. WE SHALL CONTINUE TO MONITOR THE MARKET, AND IF MEDICAL FACILITIES REPORT THE OCCURRENCE OF SIMILAR EVENTS, WE SHALL AGAIN SUBMIT A MEDICAL DEVICE REPORTING AND TAKE CORRECTIVE ACTION AS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302181 MENICON ASRB (ASMOFILCONA) SILICONE HYDROGEL SOFT CONTACT LENS LPL MENICON CO., LTD. SLON070

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention