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HANDHELD REF / KERATOMETER
NIDEK CO.,LTD. · Model HandyRef-K · UDI-DI 04987669100769
10
510(k) clearances
173
Adverse events
5
Recalls
76
Facilities
Description
The NIDEK HANDHELD REF/KERATOMETER, HandyRef-K, 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) in the steepest and flattest meridian directions, cylinder axis, and corneal cylindrical power. This device is a hand-held model that allows measurement of children who cannot hold their head on the stationary chinrest, bed-ridden patients or patients in an operating room.
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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Get your free API keyRead the docsData 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.