Nidek Inc: Medical Device Recall in 2016 - (Recall #: Z-1245-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eye for purpose of determining refractive error and binocular functions.

Product Classification:

Class II

Date Initiated: February 29, 2016

Date Posted: March 30, 2016

Recall Number: Z-1245-2016

Event ID: 73316

Reason for Recall:

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 of patient.

Status: Terminated

Product Quantity: 2703 separate serial numbers

Code Information:

serial numbers: See attached distribution list. 128 RT -3100 and 2565 RT-5100.

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated