REFRACTOR

NIDEK CO.,LTD. · Model RT-3100 · UDI-DI 04987669100813

HKN Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The NIDEK REFRACTOR Model RT-3100 is a computerized refractor used for subjective refraction with the NIDEK AUTO REFRACTOMETER (AR), AUTO REF/KERATOMETER (ARK), AUTO REF/ KER/TONOMETER (RKT), or AUTO LENSMETER (LM) via Eye Care card. The RT-3100 includes a refractor head, control box, and relay box. The relay box not only connects the other two units, but also connects the Chart Presenting device or PC. The control box includes the key panel, display, and printer. The display is a touch-screen panel. The control box displays the data and can be used for almost all operations. In addition, the control box operates the refractor head and the connected chart presenting device. It allows the refractor and charts to be controlled together. Normally, the relay box is installed on the system table (not included in the RT-3100 package.)

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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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.