BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENICON ASRB (ASMOFILCONA)

    MDR report key: 9686166 · Received February 10, 2020

    Report

    Report Number
    1000188353-2019-00001
    Event Type
    Injury
    Date Received
    February 10, 2020
    Report Date
    February 12, 2020
    Manufacturer
    MENICON CO., LTD.
    Product Code
    LPL
    PMA / PMN Number
    K180004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORNEAL ULCER IS KNOWN AS ONE OF ADVERSE EVENTS DUE TO WEARING CONTACT LENSES. AT THIS PRODUCT, THE FREQUENCY OF OCCURRENCE IS VERY LOW. WE COULD NOT GET DETAILED INFORMATION FROM DR. AND PATIENT ENOUGH, AND THE RELATIONSHIP OF USING THIS PRODUCT AND THE OCCURRENCE OF THIS ADVERSE EVENT IS UNKNOWN. SO WE DID NOT TAKE AN ACTION. WE KEEP WATCHING THE OCCURRENCE OF SIMILAR ADVERSE EVENT. IF THE TREND CHANGE IS DETECTED, WE WILL CONSIDER THE NECESSITY OF TAKING AN ACTION. WE HAD SENT THIS SUBMISSION ON DECEMBER 26TH, 2019 AS FOLLOW-UP REPORT 2. BUT WE NOTICED THAT ACK3 HAD INDICATED "FAILED" FEW DAYS AGO. ( CORE ID : (B)(6) ). WE CONSULTED WITH FDA MDR TEAM, AND IT WAS CLEARED THAT THE UPDATE OF ESUBMITTER WE USED WAS NOT ADEQUATE. SO WE REMADE THIS SUBMISSION BY USING THE LATEST VERSION ESUBMITTER AND RESENT IT.

    Additional Manufacturer Narrative · 0

    WE HAD SENT THIS SUBMISSION ON DECEMBER 5TH, 2019 AS FOLLOW-UP REPORT 1. BUT WE NOTICED THAT ACK3 HAD INDICATED "FAILED" FEW DAYS AGO. ( CORE ID : (B)(4) ) WE CONSULTED WITH FDA MDR TEAM, AND IT WAS CLEARED THAT THE UPDATE OF ESUBMITTER WE USED WAS NOT ADEQUATE. SO WE REMADE THIS SUBMISSION BY USING THE LATEST VESION ESUBMITTER AND RESENT IT.

    Description of Event or Problem · 0

    THIS EVENT OCCURRED IN JAPAN. THE PATIENT WORE 2WEEK MENICON PREMIO(2W REPLACEMENT CL, DAILY WEAR), WHICH IS SIMILAR DEVICE OF MENICON ASRB (ASMOFILCON A) SILICONE HYDROGEL SOFT CONTACT LENS (K180004). SITUATION ; ON (B)(6) 2019, THE PATIENT VISITED TO THE MENICON-OWNED CL STORE ( HEREINAFTER, REFERRED TO AS "THE STORE" ), AND SAID THAT HIS RIGHT EYE HAD GOT CORNEAL ULCER ABOUT A MONTH BEFORE, AND HIS VISUAL ACUITY HAD NOT RECOVERED YET. THE PATIENT WAS THE MEMBER OF MELSPLAN (MENICON'S CONTACT LENS MEMBERSHIP). HE VISITED THE STORE TO TERMINATE HIS MEMBERSHIP ON (B)(6) 2019. HE SAID THE REASON OF THE TERMINATION IS HIS FREQUENCY OF CONTACT LENS USE BECAME DECLINE. THE CONCERNED LENS THE PATIENT WORE WAS NOT AVAILABLE. THE STORE STAFF CONFIRMED THAT THE PATIENT FOLLOWED THE INSTRUCTIONS FOR USE. THE STORE STAFF COULDN'T GET FURTHER INFORMATION (INCLUDING THE NAME AND ADDRESS OF THE OPHTHALMOLOGIST)BECAUSE THE PATIENT WAS IN A HURRY. AT A LATER DATE, THE STORE STAFF CALLED HIM SEVERAL TIMES BUT THE CALL DIDN'T GET THROUGH, THEN THE STORE STAFF SENT A LETTER TO HIM BUT IT CAME BACK BECAUSE OF THE DESTINATION UNKNOWN. THEREFORE, WE STILL HAVE NOT BEEN ABLE TO CONTACT THE PATIENT AGAIN. THE PATIENT CANCELLED MELSPLAN, BUT HE HAS BEEN ENTITLED TO RECEIVE THE HIS CONTACT LENSES UNTIL (B)(6) 2019. WHEN THE PATIENT VISITS THE STORE TO RECEIVE HIS CONTACT LENSES, WE WILL TRY TO GET MORE INFORMATION ABOUT RECOVERY SITUATION AND OPHTHALMOLOGIST THE PATIENT HAD VISITED FOR HIS CORNEAL ULCER. [AT 1ST. FOLLOW-UP REPORT, THE FOLLOWING IS ADDED.] THE PATIENT DID NOT VISIT THE STORE. SO THE STORE STAFF CALLED HIM ON NOV., 9TH, 2019. THE FOLLOWING INFORMATION AND HOSPITAL INFORMATION WAS AVAILABLE. PATIENT'S VISUAL ACUITY IS RECOVERING (VISION WITH CORRECTION: 20/33(6/10)). DR DIRECTED HIM TO STOP WEARING CLS. PATIENT WAS DIAGNOSED AS FUNGAL CORNEAL ULCER. 4 EYE DROPS WERE PRESCRIBED (DOSAGE: 2-4 TIMES/DAY). WE WILL TRY TO GET MORE INFORMATION ABOUT THIS PATIENT FROM OPHTHALMOLOGIST. [AT FINAL REPORT, THE FOLLOWING IS ADDED.] ON NOVEMBER 21TH, 2019, MENICON INQUIRED THE MEDICAL OFFICE OF THE UNIVERSITY HOSPITAL BY EMAIL WHETHER WE COULD HAVE AN INTERVIEW WITH DR. ABOUT THIS PATIENT. ON NOVEMBER 25TH, 2019, MENICON CALLED THE OUTPATIENT CLINIC OF THE UNIVERSITY HOSPITAL BECAUSE OF NO REPLY. THE CLINIC STAFF SAID THAT ID NUMBER WAS NEEDED TO IDENTIFY THE PATIENT AND DISCLOSE PATIENT'S INFORMATION. ON NOVEMBER 25TH, 2019, THE STORE STAFF CALLED THE PATIENT AGAIN AND COULD GET THROUGH. DR'S NAME WAS AVAILABLE, BUT ID NUMBER WAS NOT AVAILABLE. (THE PATIENT SAID THAT HE WOULD CONTACT US LATER.) ON DECEMBER 14TH AND 16TH, 2019, THE STORE STAFF CALLED THE PATIENT AGAIN (2 TIMES) BUT THE CALL DIDN'T GET THROUGH. ON DECEMBER 17TH, 2019, MENICON CALLED THE OUTPATIENT CLINIC OF THE UNIVERSITY HOSPITAL AGAIN AND INQUIRED WHETHER WE COULD HAVE AN INTERVIEW AND DISCLOSURE OF PATIENT'S INFORMATION BY ONLY DR.'S NAME AND PATIENT'S NAME OR NOT. THE CLINIC STAFF SAID THAT SHE WOULD CONFIRM DR. ABOUT THIS. ON DECEMBER 18TH, 2019, MENICON CALLED THE OUTPATIENT CLINIC OF THE UNIVERSITY HOSPITAL AGAIN. THE CLINIC STAFF SAID THAT DR. REQUESTED THE WRITTEN CONSENT BY PATIENT UPON DISCLOSURE OF INFORMATION, SO IT WAS IMPOSSIBLE TO DISCLOSE INFORMATION WITHOUT IT. MENICON EXPLAINED THAT WE HAD THE ORAL CONSENT AND DISCLOSURE BASED ON LAWS AND REGULATIONS WAS EXEMPT FROM PERSONAL INFORMATION PROTECTION LAW. BUT THE CLINIC STAFF REFUSED OUR REQUEST. WE THOUGHT THAT IT WAS HARD TO GET WRITTEN CONSENT FROM PATIENT FROM FOLLOWING REASONS ; A LETTER TO PATIENT CAME BACK BECAUSE OF THE DESTINATION UNKNOWN. PATIENT WOULD NOT ANSWER THE STORE STAFF'S CALL. SO WE CONCLUDED THAT IT WAS IMPOSSIBLE TO COLLECT MORE INFORMATION ABOUT PATIENT.

    Description of Event or Problem · 0

    THIS EVENT OCCURRED IN JAPAN. THE PATIENT WORE 2WEEK MENICON PREMIO(2W REPLACEMENT CL, DAILY WEAR), WHICH IS SIMILAR DEVICE OF MENICON ASRB (ASMOFILCON A) SILICONE HYDROGEL SOFT CONTACT LENS (K180004). SITUATION ; ON (B)(6) 2019, THE PATIENT VISITED TO THE MENICON-OWNED CL STORE ( HEREINAFTER, REFERRED TO AS "THE STORE" ), AND SAID THAT HIS RIGHT EYE HAD GOT CORNEAL ULCER ABOUT A MONTH BEFORE, AND HIS VISUAL ACUITY HAD NOT RECOVERED YET. THE PATIENT WAS THE MEMBER OF MELSPLAN (MENICON'S CONTACT LENS MEMBERSHIP). HE VISITED THE STORE TO TERMINATE HIS MEMBERSHIP ON (B)(6) 2019. HE SAID THE REASON OF THE TERMINATION IS HIS FREQUENCY OF CONTACT LENS USE BECAME DECLINE. THE CONCERNED LENS THE PATIENT WORE WAS NOT AVAILABLE. THE STORE STAFF CONFIRMED THAT THE PATIENT FOLLOWED THE INSTRUCTIONS FOR USE. THE STORE STAFF COULDN'T GET FURTHER INFORMATION (INCLUDING THE NAME AND ADDRESS OF THE OPHTHALMOLOGIST)BECAUSE THE PATIENT WAS IN A HURRY. AT A LATER DATE, THE STORE STAFF CALLED HIM SEVERAL TIMES BUT THE CALL DIDN'T GET THROUGH, THEN THE STORE STAFF SENT A LETTER TO HIM BUT IT CAME BACK BECAUSE OF THE DESTINATION UNKNOWN. THEREFORE, WE STILL HAVE NOT BEEN ABLE TO CONTACT THE PATIENT AGAIN. THE PATIENT CANCELLED MELSPLAN, BUT HE HAS BEEN ENTITLED TO RECEIVE THE HIS CONTACT LENSES UNTIL (B)(6) 2019. WHEN THE PATIENT VISITS THE STORE TO RECEIVE HIS CONTACT LENSES, WE WILL TRY TO GET MORE INFORMATION ABOUT RECOVERY SITUATION AND OPHTHALMOLOGIST THE PATIENT HAD VISITED FOR HIS CORNEAL ULCER. [AT 1ST. FOLLOW-UP REPORT, THE FOLLOWING IS ADDED.] THE PATIENT DID NOT VISIT THE STORE. SO THE STORE STAFF CALLED HIM ON (B)(6) 2019. THE FOLLOWING INFORMATION AND HOSPITAL INFORMATION WAS AVAILABLE. PATIENT'S VISUAL ACUITY IS RECOVERING (VISION WITH CORRECTION: 20/33(6/10)). DR DIRECTED HIM TO STOP WEARING CLS. PATIENT WAS DIAGNOSED AS FUNGAL CORNEAL ULCER. 4 EYE DROPS WERE PRESCRIBED (DOSAGE: 2-4 TIMES/DAY). WE WILL TRY TO GET MORE INFORMATION ABOUT THIS PATIENT FROM OPHTHALMOLOGIST.

    Additional Manufacturer Narrative · 1

    WE HAD SENT THIS SUBMISSION ON (B)(6) 2019 AS INITIAL REPORT. BUT WE NOTICED THAT ACK3 HAD INDICATED "FAILED" FEW DAYS AGO. ( CORE ID : (B)(6). WE CONSULTED WITH FDA MDR TEAM, AND IT WAS CLEARED THAT THE UPDATE OF ESUBMITTER WE USED WAS NOT ADEQUATE. SO WE REMADE THIS SUBMISSION BY USING THE LATEST VESION ESUBMITTER AND RESENT IT.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN (B)(6). THE PATIENT WORE 2WEEK MENICON PREMIO(2W REPLACEMENT CL, DAILY WEAR), WHICH IS SIMILAR DEVICE OF MENICON ASRB (ASMOFILCON A) SILICONE HYDROGEL SOFT CONTACT LENS (K180004). SITUATION ; ON (B)(6) 2019, THE PATIENT VISITED TO THE MENICON-OWNED CL STORE ( HEREINAFTER, REFERRED TO AS "THE STORE" ), AND SAID THAT HIS RIGHT EYE HAD GOT CORNEAL ULCER ABOUT A MONTH BEFORE, AND HIS VISUAL ACUITY HAD NOT RECOVERED YET. THE PATIENT WAS THE MEMBER OF MELSPLAN (MENICON'S CONTACT LENS MEMBERSHIP). HE VISITED THE STORE TO TERMINATE HIS MEMBERSHIP ON (B)(6) 2019. HE SAID THE REASON OF THE TERMINATION IS HIS FREQUENCY OF CONTACT LENS USE BECAME DECLINE. THE CONCERNED LENS THE PATIENT WORE WAS NOT AVAILABLE. THE STORE STAFF CONFIRMED THAT THE PATIENT FOLLOWED THE INSTRUCTIONS FOR USE. THE STORE STAFF COULDN'T GET FURTHER INFORMATION (INCLUDING THE NAME AND ADDRESS OF THE OPHTHALMOLOGIST)BECAUSE THE PATIENT WAS IN A HURRY. AT A LATER DATE, THE STORE STAFF CALLED HIM SEVERAL TIMES BUT THE CALL DIDN'T GET THROUGH, THEN THE STORE STAFF SENT A LETTER TO HIM BUT IT CAME BACK BECAUSE OF THE DESTINATION UNKNOWN. THEREFORE, WE STILL HAVE NOT BEEN ABLE TO CONTACT THE PATIENT AGAIN. THE PATIENT CANCELLED MELSPLAN, BUT HE HAS BEEN ENTITLED TO RECEIVE THE HIS CONTACT LENSES UNTIL (B)(6) 2019. WHEN THE PATIENT VISITS THE STORE TO RECEIVE HIS CONTACT LENSES, WE WILL TRY TO GET MORE INFORMATION ABOUT RECOVERY SITUATION AND OPHTHALMOLOGIST THE PATIENT HAD VISITED FOR HIS CORNEAL ULCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153365 MENICON ASRB (ASMOFILCONA) SILICONE HYDROGEL SOFT CONTACT LENS LPL MENICON CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability