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AUTO REF/KERATOMETER

NIDEK CO.,LTD. · Model ARK-1 · UDI-DI 04987669100714

HKO HLQ Prescription

510(k) clearances

173

Adverse events

Recalls

Facilities

Description

The NIDEK AUTO REF/KERATOMETER ARK-1a/ARK-1 measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye. The keratometer measures the corneal curvature radius (corneal refractive power), principal meridian directions, and corneal cylindrical power.

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.