MENICON ASRB (ASMOFILCONA)
Report
- Report Number
- 1000188353-2025-00001
- Event Type
- Injury
- Date Received
- January 14, 2025
- Date of Event
- December 14, 2024
- Report Date
- March 14, 2025
- Manufacturer
- MENICON CO., LTD.
- Product Code
- LPL
- PMA / PMN Number
- K180004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ON (B)(6) 2025, WE WERE ABLE TO OBTAIN INFORMATION FROM THE PATIENT (PT). PT'S RIGHT EYE IS STILL UNDERGOING TREATMENT. PT VISITED THE CORNEA CLINIC, WHERE SHE WAS DIAGNOSED THAT HER CORNEA IS NOT YET FULLY HEALED AND INSTRUCTED TO CONTINUE USING EYE DROPS (PRESCRIBED EYE DROPS WERE UNKNOWN). WE ATTEMPTED TO OBTAIN INFORMATION ON PT OUTCOMES, ETC., BUT THIS WAS NOT POSSIBLE. THEREFORE, NO ADDITIONAL INFORMATION BEYOND THE ABOVE WAS OBTAINED. 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.
THIS EVENT OCCURRED IN UK. THE PATIENT WORE EYEXPERT CHERISH, WHICH IS A SIMILAR DEVICE OF MENICON ASRB (ASMOFILCON A) SILICONE HYDROGEL SOFT CONTACT LENS (K180004). THE PATIENT WAS SWITCHED TO EYEXPART CHERICH IN (B)(6) 2024. SHE NOTED REDNESS 4-5 DAYS AFTER INSERTING NEW CONTACT LENSES. SHE ATTENDED HER LOCAL HOSPITAL EYE SERVICE AND WAS DIAGNOSED WITH ACANTHAMOEBA KERATITIS. THE FIRST RECORD BY THE OPTOMETRIST WAS ON (B)(6) 2024 AND WE RECEIVED THE INFORMATION FROM OUR DISTRIBUTOR ON 17 DECEMBER 2024. WE ARE REQUESTING FURTHER INFORMATION FROM OUR DISTRIBUTOR AND THE OPTOMETRIST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2012184 | MENICON ASRB (ASMOFILCONA) | SILICONE HYDROGEL SOFT CONTACT LENS | LPL | MENICON CO., LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention| H |