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AUTO REF/KERATOMETER

Ningbo Ming Sing Optical R & D Co., Ltd. · Model KR-9000 · UDI-DI 06971821402004

HKO Prescription

510(k) clearances

173

Adverse events

Recalls

Facilities

Description

This instrument is used to measure the spherical refractive-power, cylindrical refractive power, the direction of astigmatic axis. KR-9000 Auto ref/keratometer Has the functions of both refractometer and keratometer Adopts the latest ARM processor and image processing technology—fast system and more clear images Mature technique from Japan. Humanized auto mist test process: will reduce the errors caused by human eye adjustments—more accurate measure results Integral pressing and CNC machining for the optical rack: ensure the measurement consistency and accuracy—more stable system 5.7" LCD screen provides more comfortable interface Supports data transmission with auto phoropter, improving the work efficiency Auto PD measurement One-key lock function, enables to lock the moving head faster Novel design and ergonomic structure give the customer sense of beauty and comfortable operation.

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

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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.