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Medizs Auto Refractometer-Keratometer
MEDIZS Inc. · Model RK-11 · UDI-DI 08809358430291
10
510(k) clearances
173
Adverse events
5
Recalls
76
Facilities
Description
Medizs Auto Refractometer-Keratometer RK-11 is a refraction device to measure Both of Refractometry & Keratometry. And also, it is able to take patient's PD, Axis and Cylinder value for a prescription of vision correction.
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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