Nidek Inc: Medical Device Recall in 2014 - (Recall #: Z-1853-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd., Aichi, Japan. Instrument provides means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subject's eyes for purpose of determining refractive error and binocular functions.

Product Classification:

Class II

Date Initiated: June 9, 2014

Date Posted: July 2, 2014

Recall Number: Z-1853-2014

Event ID: 68485

Reason for Recall:

Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.

Status: Terminated

Product Quantity: ~4,285 units RT-5100; 167 units of RT-3100

Code Information:

RT-5100 and RT-3100, various serial numbers.

Distribution Pattern:

US distribution only.

Voluntary or Mandated:

Voluntary: Firm initiated