BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENICON ASRB (ASMOFILCON A) SILICONE HYDROGEL SOFT CONTACT LENS

    MDR report key: 24625139 · Received March 18, 2026

    Report

    Report Number
    1000188353-2026-00003
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    February 15, 2026
    Report Date
    March 18, 2026
    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 2 WEEK MENICON PREMIO (2 WEEK REPLACEMENT CONTACT LENS, DAILY WEAR), WHICH IS A SIMILAR DEVICE OF MENICON ASRB (ASMOFILCON A) SILICONE HYDROGEL SOFT CONTACT LENS (K180004). ON (B)(6) 2026, THE PATIENT (PT) WAS SEEN BY AN OPHTHALMOLOGIST DUE TO PAIN IN HER LEFT EYE AND WAS DIAGNOSED WITH A CORNEAL ULCER. PT WAS PRESCRIBED LEVOFLOXACIN, BESTRON, AND OFLOXACIN, AND WAS INSTRUCTED TO CONTINUE FOLLOW-UP VISITS. ON (B)(6) 2026, THE PT RETURNED FOR A FOLLOW-UP EXAMINATION AND WAS DIAGNOSED AS HAVING RECOVERED FROM THE CORNEAL ULCER. WE RECEIVED THE LENS FROM THE PT AND CONDUCTED AN INVESTIGATION ON 3 MARCH 2026. DETAILS OF THE INVESTIGATION RESULTS ARE SHOWN IN B6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299610 MENICON ASRB (ASMOFILCON A) SILICONE HYDROGEL SOFT CONTACT LENS LENSES, SOFT CONTACT, DAILY WEAR LPL MENICON CO., LTD. SAFP07101 OR SECP02001

    Patients

    Seq Age Sex Outcome Treatment
    1