BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENICON ASRB (ASMOFILCONA)

    MDR report key: 21300959 · Received February 4, 2025

    Report

    Report Number
    1000188353-2025-00003
    Event Type
    Injury
    Date Received
    February 4, 2025
    Date of Event
    September 29, 2024
    Report Date
    March 19, 2025
    Manufacturer
    MENICON CO., LTD.
    Product Code
    LPL
    PMA / PMN Number
    K180004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    WE WERE ABLE TO OBTAIN AN UNUSED LENS FROM THE SAME LOT AS THE LENSES IN QUESTION FROM THE PATIENT, BUT DUE TO INSUFFICIENT INFORMATION, THE METHOD OF INVESTIGATION HAS NOT BEEN DETERMINED AT THIS TIME.

    Description of Event or Problem · 0

    SINCE THE INITIAL REPORT, WE HAVE ATTEMPTED TO COLLECT FURTHER INFORMATION FROM OPTICAL SHOP (INITIAL REPORTER), BUT HAVE BEEN UNABLE TO OBTAIN INFORMATION ON PATIENTS' REGULAR CHECKUPS OR OUTCOMES. 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.

    Description of Event or Problem · 0

    THIS EVENT OCCURRED IN GERMANY. THE PATIENT WORE PRO EYES KONTAKTLINSEN KOMFORT PLUS SPHARISCH, WHICH IS A SIMILAR DEVICE OF MENICON ASRB (ASMOFILCON A) SILICONE HYDROGEL SOFT CONTACT LENS (K180004). ON (B)(6)2024, PATIENT(PT) PRESENTED TO THE EMERGENCY DEPARTMENT OF A HOSPITAL IN GERMANY WITH A CORNEAL ULCER AND ACCOMPANYING ANTERIOR CHAMBER IRRITATION AND HYPOPYON IN THE RIGHT EYE. PT MENTIONED THAT SHE HAD NOTICED AN INCREASING DETERIORATION IN VISION OVER THE PAST FEW DAYS. THE EXAMINATION REVEALED THE ABOVE FINDINGS IN THE RIGHT EYE UNDER THE SLIT LAMP MICROSCOPE, THIS RESULTED IN HER BEING HOSPITALIZED FOR FURTHER TREATMENT. A CORNEAL SWAB WAS TAKEN TO DETERMINE THE PATHOGEN. BOTH THE HERPES PCR AND THE VZV(VARICELLA ZOSTER VIRUS) PCR SHOWED NEGATIVE RESULTS. PSEUDOMONAS AERUGINOSA WAS DETECTED IN CULTURE. LOCAL THERAPY ON THE RIGHT EYE WITH REFO FORTIFIED 1.4% AT(GENTAMICIN EYE DROPS) AND FLOXAL AT(OFLOXACIN EYE DROPS) ALTERNATING EVERY HALF HOUR, OFLOXACIN AND GENTAMICIN OINTOMENT AT NIGHT AND BOROSCOPOL AT(SCOPOLAMINE BUTYL BROMIDE EYE DROPS) TWICE DAILY. AND INTRAVENOUS ANTIBIOTICS WITH PIPERACILLIN + TAZOBACTAM 4.5G 3 TIMES DAILY AND MOXIFLOXACIN 400MG DAILY. IN ADDITION, SYSTEMIC ORAL THERAPY WITH DECORTIN 20MG(PREDNISOLONE) WAS STARTED. OVER TIME, THERE WAS INCREASING IMPROVEMENT IN THE FINDINGS WITH CLEARING OF THE CORNEA AND REDUCTION OF THE IRRITATION. ON (B)(6)2024, MEDICAL DOCTOR INDICATED THAT THE PT COULD BE DISCHARGED IF HER CONDITION IMPROVED AND THAT REGULAR CHECKUPS WOULD BE NECESSARY AND THAT SHE WOULD NEED TO BE SEEN ON (B)(6)2024. <DISCHARGE PRESCRIPTION> BEPANTHENE OINTMENT 5TIMES A DAY, REFO FORTIFIED 1.4%(GENTAMICIN EYE DROPS) T.I.D., GENTAMICIN OINTMENT Z.N., OXYTETRACYCLINE OINTMENT B.I.D., BOROSCOPOL (SCOPOLAMINE BUTYL BROMIDE EYE DROPS) B.I.D. P.O.: DECORTIN 20MG (PREDNISOLONE) S.I.D., PANTOPRAZOLE 40MG S.I.D., CALCIUM 1000MG S.I.D., VIGANTOLETTEN 1000 IE(EQUIVALENT TO 1000 IU OF VITAMIN D) S.I.D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246703 MENICON ASRB (ASMOFILCONA) SILICONE HYDROGEL SOFT CONTACT LENS LPL MENICON CO., LTD. SBHN173

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention| H