Withdrawal of medical-device approval due to efficacy or safety issues
First written in FY2021. 2 of 6 entries say "Worsened", first in FY2024. Latest entry: 2026-05-14.
The whole theme swung hardest in 2026: 3 of 7 companies on the "Worse" side.
1 other company's latest entry also says "Mitigated".
- 2026-05-14MitigatedEarningsSuggests it is closing out
「As announced on 16 October 2025, product recalls and software modifications have been completed, and the product has now made a fresh start as MEOCHECK NEO.」
The company disclosed completion of the recall and software modifications related to MEOCHECK's regulatory compliance issue, followed by a relaunch as MEOCHECK NEO. - FY2026-H1MitigatedAnnual report
「As announced on 16 October 2025, we have completed the product recall and software modification. We will continue to take every possible measure to ensure product quality and safety and compliance with applicable laws and regulations.」
Regarding the regulatory compliance issue concerning MEOCHECK, it states that the product recall and software modification have been completed, indicating progress in the response. - FY2025WorsenedAnnual report
「It was determined that the recommendation to seek medical attention based on the results of “MEOCHECK” constituted a diagnosis, and we are proceeding with a voluntary product recall and software modification.」
Regarding regulatory compliance risks in the medical and pharmaceutical fields, a specific issue was identified with MEOCHECK, requiring product recall and modification. - FY2024WorsenedAnnual report
「Products sold or provided as non-medical devices may be determined to constitute medical devices as a result of the enactment, publication or amendment of relevant laws, regulations, guidelines or other requirements, making it necessary to take corresponding action.」
In addition to the risk of medical device approval being withdrawn due to efficacy or safety issues, it explicitly identifies the risk that products provided as non-medical devices may be determined to constitute medical devices as a result of changes in laws, regulations or other requirements. - FY2022RestatedAnnual report
「If efficacy or safety issues arise, the approval may be withdrawn.」
It reiterates the risk of medical device approval being withdrawn due to efficacy or safety issues. - FY2021First statedAnnual report
「If efficacy or safety issues arise, the approval may be withdrawn.」
It describes the regulatory and pharmaceutical-related risks applicable to retinal-scanning laser eyewear as a medical device.