YEASN
Chongqing Yeasn Science & Technology Co.,Ltd. · Model YPC-100 · UDI-DI 06971922136037
10
510(k) clearances
179
Adverse events
5
Recalls
75
Facilities
Description
The eye refractometer measures the objective refractive errors (including spherical, cylindrical refractive errors, cylinder axis) and corneal curvature radius of the patient’s eye (including corneal refractive power, principle meridian directions, and corneal cylindrical power). Note: YPC-100 has no corneal curvature measurement function, while YPC-100K has corneal curvature measurement function.
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.