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MOPTIM

Shenzhen CERTAINN Technology Co., Ltd. · Model iRef · UDI-DI 06972039971542

HKO

510(k) clearances

178

Adverse events

Recalls

Facilities

Description

The manual refractometer is composed of a lens and a removable eye chart. The testee is required to move the position of the eye chart after resetting to make the visual target become clearer from blur. Once the clearest position of the visual target is determined, the testee’s estimated refractive error can be read from the display screen of the instrument.

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.