Home › Suzhou Microclear Medical Instruments Co., Ltd. › Microclear

Microclear

Suzhou Microclear Medical Instruments Co., Ltd. · Model VS · UDI-DI 06970990160104

HKO

510(k) clearances

173

Adverse events

Recalls

Facilities

Recalls

Date	Firm	Reason
2026-02-18	Baxter Healthcare Corporation	Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
2020-08-06	Carl Zeiss Meditec AG	Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectiveness of the communication board cannot be guaranteed in that the safety
2017-12-20	Nidek Inc.	There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.
2015-06-15	Nidek Inc	Software bug was found where there was no difference in Total and Corneal high-order aberrations, but differences were found in Internal high-order aberrations.
2012-12-05	Canon Inc.	Canon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that measurement value of RK-F2s refractive power (SPH value) sometimes indicate

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.