BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENICON ASRB (ASMOFILCONA)

    MDR report key: 18000753 · Received October 25, 2023

    Report

    Report Number
    1000188353-2023-00002
    Event Type
    Injury
    Date Received
    October 25, 2023
    Date of Event
    September 26, 2023
    Report Date
    January 24, 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

    SEVERAL ATTEMPTS WERE MADE TO CONTACT THE PATIENT AFTER WE SUBMITTED OUR INITIAL REPORT, BUT NO RESPONSE WAS RECEIVED. ON (B)(6) 2023, THE ANALYTICAL RESULTS WERE OBTAINED AND NO ABNORMALITIES WERE FOUND (DETAILS ARE IN B6). ON (B)(6) 2023, WE WERE ABLE TO CONTACT THE PATIENT, BUT SHE HAD NOT SEEN AN OPHTHALMOLOGIST SINCE (B)(6) 2023. REGARDING HER EYE CONDITION, SHE STATED THAT HER VISION HAD CALMED DOWN AND WAS IMPROVING. SHE RESUMED WEARING HARD CONTACT LENSES.

    Description of Event or Problem · 0

    SEVERAL ATTEMPTS WERE MADE TO CONTACT THE PATIENT AFTER WE SUBMITTED OUR FIRST FOLLOW-UP REPORT, BUT NO RESPONSE WAS RECEIVED. ON 25DEC2023, WE OBTAINED INFORMATION FROM THE STORE WHERE THE PATIENT RECEIVED THE LENSES IN QUESTION. THE STORE STAFF PROVIDED THE FOLLOWING INFORMATION. THE PATIENT HAD CONDUCTED THREE TIMES OF LENS TRIAL AND SHE HAD NO PROBLEMS WITH THE FIRST FITTING. THE PATIENT HAD PREVIOUSLY HAD TWO TRIALS OF THE SAME LENSES (LOT NUMBERS WERE SFIL04702 AND SDML07002 WITH LENS POWERS OF -9.50/-11.50, RESPECTIVELY). THE PATIENT HAS NOT BEEN SEEN THE STORE OR OPHTHALMOLOGIST SINCE (B)(6) 2023. REGARDING THE PATIENT'S EYE CONDITION, IT IS UNLIKELY THAT SHE HAS PERMANENT SYMPTOMS, AS HER VISUAL ACUITY IS RECOVERING AND SHE HAS BEEN ABLE TO RESUME WEARING HARD CONTACT LENS AT HER OWN DECISION. SINCE THERE WERE NO ABNORMALITIES IN THE MANUFACTURING RECORDS OF THE LENSES IN QUESTION OR STORED SAMPLES, WE DO NOT BELIEVE THAT THE EVENT WAS CAUSED BY A PRODUCT DEFECT. WE HAD NO CONTACT WITH THE PATIENT AND IT WAS DIFFICULT TO OBTAIN PERMISSION TO INTERVIEW FROM THE MEDICAL FACILITIES. IN ADDITION, THE PATIENT DID NOT VISIT THE STORE OR OPHTHALMOLOGIST. BASED ON THE ABOVE, WE HAVE DETERMINED THAT IT IS DIFFICULT TO GATHER ANY FURTHER INFORMATION AND THAT THE CASE IS CLOSED.

    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). SITUATION ; THE FOLLOWING INFORMATION IS NOT FROM HEALTH CARE PROFESSIONALS, BUT FROM THE PATIENT. ON (B)(6) 2023, THE PATIENT WORE THE LENSES FOR A COUPLE OF HOURS, AND WHEN SHE REMOVED THEM, SHE EXPERIENCED SEVERE PAIN IN BOTH EYES. HER EYES WERE SWOLLEN AND SHE WAS UNABLE TO OPEN THEM. SHE WAS TRANSPORTED TO MEDICAL FACILITY A. SHE HAD ANAPHYLAXIS-LIKE SYMPTOMS. ON (B)(6) 2023, SHE WAS SEEN AT MEDICAL FACILITY B, HER DOCTOR TOLD HER THAT SHE HAD CORNEAL DAMAGE, CORNEAL OPACITY, BLEEDING IN HER EYES, AND THE DOCTOR PRESCRIBED FIVE MEDICATIONS (TWO OF WHICH WERE ALLERGY MEDICATIONS). SHE HAD DIFFICULTY WALKING WITHOUT ASSISTANCE DUE TO POOR VISION. SHE WAS TO BE TREATED ON AN OUTPATIENT BASIS AND IS STILL RECUPERATING. ON (B)(6) 2023, SHE COULD WALK WITHOUT ASSISTANCE. SHE VISITED MEDICAL FACILITY B, THE DOCTOR TOLD HER TO CONTINUE TAKING THE MEDICATIONS PRESCRIBED ON (B)(6) 2023. ON (B)(6) 2023, SHE VISITED MEDICAL FACILITY B. THERE WAS A CHANGE IN PRESCRIPTION MEDICATIONS (DETAILS OF THE PRESCRIPTION MEDICATIONS WERE NOT AVAILABLE). ON (B)(6) 2023, SHE TOLD THAT HER VISION HAD IMPROVED COMPARED TO THE DATE OF THE EVENT, BUT IT WAS NOT STABLE. WE HAVE ATTEMPTED TO CONTACT HER BUT HAVE NOT RECEIVED ANY ADDITIONAL INFORMATION. WE ALSO ATTEMPT TO OBTAIN CONSENT FROM THE PATIENT TO COLLECT INFORMATION FROM THE MEDICAL FACILITIES. HOWEVER, SINCE THIS HAS NOT YET BEEN OBTAINED, WE HAVE NOT BEEN ABLE TO CONTACT THE MEDICAL FACILITIES DIRECTLY. WE WILL CONTINUE TO ATTEMPT TO GATHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1838127 MENICON ASRB (ASMOFILCONA) SILICONE HYDROGEL SOFT CONTACT LENS LPL MENICON CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Disability