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Vision Screener
Huvitz Co., Ltd. · Model HVS-1 · UDI-DI 08800019600954
10
510(k) clearances
178
Adverse events
5
Recalls
76
Facilities
Description
The HVS-1 is a hand-held Vision Screener designed to measure the refractive power of the eye, providing Sphere (SPH), Cylinder (CYL), and Axis (AXS) data, as well as Pupillary Distance (PD) and pupil size.
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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