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Tabletop Refraction System

NIDEK CO.,LTD. · Model TS-310 · UDI-DI 04987669101414

510(k) clearances

Adverse events

Recalls

Facilities

Description

The TS-310 is a space-saving automated refraction system that uses a combination of the refractor head of the RT-3100 and a control box. • With the high precision LCD, visual acuity of 5 m as well as near visual acuity of 40 cm can be measured with the same accuracy as a standard refraction using actual distances. • The objective data measured by a NIDEK auto refractometer and the lensometry data measured by a NIDEK lensmeter can be imported and used in this device.

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.