Home › NIDEK CO.,LTD. › Fully Assisted Refraction System

Fully Assisted Refraction System

NIDEK CO.,LTD. · Model FARS · UDI-DI 04987669203552

HKN Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

In the conventional refraction, the patient answers the operator’s questions. According to their answers, the operator performs subjective refraction such as refining refractive errors (sphere, cylinder, prism, and such) and proceeding to the next test. In this system, the patient responds to refraction questions by themselves using the Joystick Controller in response to the voice guide from the computer. The system application enables subjective refraction according to patient operation to determine the full correction.

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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.