Z-1245-2016Class II

RT-5100 (Epic 5100) Refractor and RT 3100 Refractor

Name: Z-1245-2016 RT-5100 (Epic 5100) Refractor and RT 3100 Refractor
Creator: Nidek Inc
Published: 2016-02-29
License: https://open.fda.gov/license/

Nidek Incorporated / initiated 2016-02-29 / Terminated / root cause: design

FDA source

Nidek Inc began a recall of RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical and cylindrical lenses, prisms and... on 2016-02-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1245-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-29
Posted: 2016-03-24
Terminated: 2018-09-24
Recalling firm: Nidek Incorporated
Product: 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 code: HKN Refractor, Manual, Non-Powered, Including Phoropter
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: Nidek sent a Recall letters dated February 29, 2016 to all affected site. The letter identified the affected product, problem and actions to be taken. Nidek Customer Service will be replacing the affected product with new parts to address this recall. For questions call Customer Service at 1-800-722-0219.
Quantity in commerce: 2703 separate serial numbers
Distribution: US Nationwide Distribution
Product codes and lots: serial numbers: See attached distribution list. 128 RT -3100 and 2565 RT-5100.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1245-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1245-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-24

Product code HKN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)