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MOPTIM
Shenzhen CERTAINN Technology Co., Ltd. · Model easyRef · UDI-DI 06972039971573
3
510(k) clearances
39
Adverse events
7
Recalls
64
Facilities
Description
The key technique used in the easyRef Handheld Auto Refractometer is based on principle of Hartmann wave-front sensing. Light is emitted from the light source system inside the device, and then focuses on the bottom of the eye through the spectroscope and exit port, then the light is reflected back to the device, and beam through lens system and received by CCD camera. It is possible to calculate the diopter of the human eye by detecting the offset between the relative calibration light and the spot array formed by the light spot of each sub-aperture.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-28 | Reichert, Inc. | The head of the phoropter head could come loose and potentially detach due to a default in the assembly. |
| 2025-02-28 | Reichert, Inc. | The head of the phoropter head could come loose and potentially detach due to a default in the assembly. |
| 2023-07-20 | Reichert, Inc. | Phoroptor VRx Head may detach from the bracket that connects the Phoroptor VRx Head to an ophthalmic stand. If the Phoroptor VRx Head detaches from the bracket, it can fall onto a |
| 2018-06-14 | Nidek Inc. | The lens bonding was incomplete on the refractor. |
| 2017-12-06 | Reliance Medical Products Inc | Product has been found with a missing Washer, Retaining Ring, and/or Stop Screw. Recalling firm was notified by distributor that Refractor Suspension Arm fell on a patient s lower |
| 2016-02-29 | Nidek Inc | There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refractor of the Near Point Chart Arm lowering spontaneously with potential for slight injury to face or nose o |
| 2014-06-09 | Nidek Inc | Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury. |
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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.