BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENICON ASRB (ASMOFILCONA)

    MDR report key: 19348759 · Received May 20, 2024

    Report

    Report Number
    1000188353-2024-00001
    Event Type
    Injury
    Date Received
    May 20, 2024
    Date of Event
    March 12, 2024
    Report Date
    September 13, 2024
    Manufacturer
    MENICON CO., LTD.
    Product Code
    LPL
    PMA / PMN Number
    K180004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THIS EVENT OCCURRED IN JAPAN. THE PATIENT WORE 2WEEK MENICON PREMIO - BIFOCAL TORIC DESIGN (2WEEK REPLACEMENT CONTACT LENS, DAILY WEAR), WHICH IS A SIMILAR DEVICE OF MENICON ASRB (ASMOFILCON A) SILICONE HYDROGEL SOFT CONTACT LENS (K180004). SITUATION ; ON (B)(6) 2024, OUR CUSTOMER CENTER STAFF CONFIRMED AN E-MAIL FROM THE PATIENT. THE CONTENTS OF THE E-MAIL ARE AS BELOW; THE PATIENT USED THE LENSES ON (B)(6) 2024, AND SHE HAD PAIN IN HER EYES AND FELT HER VISION WAS CLOUDED. THE PATIENT VISITED MEDICAL FACILITY A ON (B)(6) 2024, THE DOCTOR TOLD HER THAT HER CORNEA WAS DAMAGED. ON 17MAR2024, OUR CUSTOMER CENTER STAFF OBTAINED ADDITIONAL INFORMATION FROM THE PATIENT. THE INFORMATION IS AS BELOW; THE PATIENT DIDN'T RECOVER AT MEDICAL FACILITY A, SO SHE VISITED A MORE SPECIALIZED MEDICAL FACILITY B. THE PATIENT WAS TOLD BY BOTH DOCTORS THAT HER CORNEAL INJURY WAS NOT CAUSED BY AN INFECTION, BUT BY THE CONTACT LENSES SHE USED ON (B)(6) 2024. THE PATIENT'S EYE HAD BEEN GETTING WORSE SINCE THE INITIAL VISIT (ON (B)(6) 2024), AND THE PATIENT VISITED THE MEDICAL FACILITY A FOR A CHECKUP. WE CONDUCTED THE LENS INSPECTION AND THE MANUFACTURING RECORDS INVESTIGATION (INSPECTION DETAILS AND RESULTS ARE PROVIDED IN B6). THE APPEARANCE TEST OF THE ACTUAL LENSES REVEALED SMALL DEPOSITS, BUT NO OTHER ABNORMALITIES WERE FOUND. WE CONTACTED THE PATIENT TO OBTAIN HER CONSENT FOR US TO COLLECT INFORMATION FROM THE MADICAL FACILITIES ON (B)(6) 2024, AND OBTAINED HER CONSENT ON (B)(6) 2024. ON 22APR2024, ADDITIONAL INFORMATION WAS OBTAINED FROM MEDICAL FACILITY A AND WE WERE INFORMED THAT THE PATIENT WAS IN A SERIOUS EVENT. THE INFORMATION OBTAINED FROM MEDICAL FACILITY A IS AS BELOW (IN CHRONOLOGICAL ORDER); ON (B)(6) 2024, THE DOCTOR DIAGNOSED THE PATIENT WITH DRUG-INDUCED EPITHELIAL DAMAGE, SPK (SLIGHT) IN RIGHT EYE, DIFFUSE SPK (MODERATE) IN LEFT EYE. THE DOCTOR PRESCRIBED 1.5% CRAVIT OPHTHALMIC SOLUTION AND 0.3% HYALEIN OPHTHALMIC SOLUTION, AND INSTRUCTED THE PATIENT TO STOP WEARING CONTACT LENSES. ON (B)(6) 2024, THE DOCTOR OBSERVED THAT BOTH OF THE PATIENT'S EYES HAD DETERIORATED AND THAT HER LEFT EYE HAD CONJUNCTIVAL HYPEREMIA. THE DOCTOR PRESCRIBED SOFT SANTEAR (ARTIFICIAL LACRIMAL SOLUTION) AND 0.1% FLUMETHOLON OPHTHALMIC SUSPENSION. ON (B)(6) 2024, THE DOCTOR FOUND THAT THE PATIENT'S RIGHT EYE WAS MILDLY AFFECTED, BUT HER LEFT EYE WAS PAINFUL AND THE PATIENT COULD NOT BE OPENED, AND OBSERVED SPK, NEOVASCULARIZATION, AND CONJUNCTIVAL HYPEREMIA IN HER LEFT EYE. THE DOCTOR PRESCRIBED TARIVID OPHTHALMIC OINTMENT FOR HER LEFT EYE. ON (B)(6) 2024, THE PATIENT VISITED THE MEDICAL FACILITY B (DETAILS ARE NOT AVAILABLE. WE PLAN TO VISIT THE MEDICAL FACILITY B TO COLLECT INFORMATION.). ON (B)(6) 2024, THE DOCTOR OBSERVED THAT THE PATIENT'S RIGHT EYE HAD RECOVERED, WHILE HER LEFT EYE HAD SPK, NEOVASCULARIZATION, AND CONJUNCTIVAL HYPEREMIA. THE DOCTOR CHANGED THE PRESCRIPTION TO ONLY TWO DRUGS, CRAVIT OPHTHALMIC SOLUTION AND TALIVIT EYE OINTMENT. ON (B)(6) 2024, THE DOCTER OBSERVED DIFFUSE SPK, AND NEOVASCULARIZATION AND CONJUNCTIVAL HYPEREMIA IN THE PATIENT'S LEFT EYE. ON AND (B)(6) 2024, THE DOCTOR EXAMINED THE PATIENT AND FOUND THAT THE HYPEREMIA AND SPK IN HER LEFT EYE HAD RESOLVED, BUT THE NEOVASCULARIZATION HAD NOT, AND SHE DID NOT RESUME WEARING CONTACT LENSES. CONCLUSION ; ALTHOUGH NO ABNORMALITIES WERE FOUND IN THE ACTUAL OR UNOPENED LENSES, AND WE WERE UNABLE TO IDENTIFY THE LENS DEFECT, THE PATIENT DEVELOPED SYMPTOMS AFTER WEARING THE LENSES, WE BELIEVE THAT A CAUSAL RELATIONSHIP WITH THE LENSES CANNOT BE RULED OUT. THE PATIENT HAS NOT RECOVERED AND WE ARE ATTEMPTING TO COLLECT FURTHER INFORMATION FROM MEDICAL FACILITIES A AND B.

    Description of Event or Problem · 0

    ON 18JUN2024, WE OBTAINED INFORMATION FROM MEDICAL FACILITY B. THE INFORMATION IS AS FOLLOWS; - ON (B)(6) 2024, THE DOCTOR OBSERVED SPK AND CONJUNCTIVAL HYPEREMIA IN THE PATIENT'S LEFT EYE. THE DOCTOR PRESCRIBED CRAVIT OPHTHALMIC SOLUTION AND TALIVIT EYE OINTMENT AND INSTRUCTED THE PATIENT TO STOP WEARING CONTACT LENSES. - ON (B)(6) 2024, THE DOCTOR OBSERVED THE PATIENT'S LEFT EYE SHOWED A TREND TOWARD IMPROVEMENT. - ON (B)(6) 2024, THE DOCTOR OBSERVED CONJUNCTIVAL HYPEREMIA IN THE PATIENT'S LEFT EYE HAD CLEARED AND HAD RECOVERED. THE DOCTOR ALLOWED THE PATIENT TO RESUME WEARING CONTACT LENSES (PRODUCT TO BE CHANGED). THE PATIENT HAD COMPLETED TREATMENT AT MEDICAL FACILITY B AS DESCRIBED ABOVE, BUT THE PATIENT CONTINUES TO VISIT MEDICAL FACILITY A. THEREFORE, WE WILL CONTINUE TO COLLECT FURTHER INFORMATION FROM MEDICAL FACILITY A.

    Description of Event or Problem · 0

    ON 21MAY2024, WE OBTAINED ADDITIONAL INFORMATION FROM MEDICAL FACILITY A. THE INFORMATION IS AS FOLLOWS; ON (B)(6) 2024, THE DOCTOR OBSERVED THE NEOVASCULARIZATION IN THE PATIENT'S LEFT EYE AND EPITHELIAL INSTABILITY. THE DOCTOR PRESCRIBED 1.5% CRAVIT OPHTHALMIC SOLUTION, 0.1% FLUMETHOLON OPHTHALMIC SUSPENSION AND HYALURONATE NA OPHTHALMIC SOLUTION 0.1%. ON (B)(6) 2024, THE DOCTOR OBSERVED A NARROWING OF THE NEOVASCULARIZATION IN THE PATIENT'S LEFT EYE AND THE EPITHELIUM SHOWED A TREND TOWARD IMPROVEMENT. THE DOCTOR PRESCRIBED THE SAME THREE DRUGS AS ABOVE. THE PATIENT HAS NOT RESUME WEARING CONTACT LENSES AND IS SCHEDULED TO VISIT MEDICAL FACILITY A IN JUNE. WE PLAN TO COLLECT UPDATES ON THE PATIENT FROM MEDICAL FACILITY A AND PLAN TO VISIT MEDICAL FACILITY B TO COLLECT INFORMATION IN JUNE.

    Description of Event or Problem · 0

    ON 20AUG2024, WE OBTAINED INFORMATION FROM MEDICAL FACILITY A. THE INFORMATION IS AS FOLLOWS; ON (B)(6) 2024, THE DOCTOR OBSERVED SPK AND NEOVASCULARIZATION THINNING IN THE PATIENT'S LEFT EYE. THE DOCTOR PRESCRIBED 1.5% CRAVIT OPHTHALMIC SOLUTION, 0.1% FLUMETRON OPHTHALMIC SUSPENSION AND 0.1% HYALURONATE NA OPHTHALMIC SOLUTION. ON (B)(6) 2024, THE DOCTOR OBSERVED A DISAPPEARANCE OF SPK AND NARROWING OF NEOVASCULARIZATION IN THE PATIENT'S LEFT EYE. THE DOCTOR CONTINUED TO PRESCRIBE 0.1% FLUMETRON OPHTHALMIC SUSPENSION AND 0.1% HYALURONATE NA OPHTHALMIC SOLUTION, AND INSTRUCTED THE PATIENT TO DISCONTINUE 1.5% CRAVIT OPHTHALMIC SOLUTION. THE DOCTOR SUGGESTED A POSSIBLE RECOVERY FOR THE PATIENT'S LEFT EYE. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED IF APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659876 MENICON ASRB (ASMOFILCONA) LENSES, SOFT CONTACT, DAILY WEAR LPL MENICON CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention