Z-1853-2014Class II

RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd...

Name: Z-1853-2014 RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd...
Creator: Nidek Inc
Published: 2014-06-09
License: https://open.fda.gov/license/

Nidek Incorporated / initiated 2014-06-09 / Terminated

FDA source

Nidek Inc began a recall of RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd., Aichi, Japan. Instrument provides means of... on 2014-06-09. FDA classified it as Class II and gives the reason as "Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1853-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-09
Posted: 2014-06-23
Terminated: 2015-10-30
Recalling firm: Nidek Incorporated
Product: 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 code: HKN Refractor, Manual, Non-Powered, Including Phoropter
Reason for recall: Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.
FDA root cause: Use error
Action: Recall/Field Correction letters were sent to doctors on June 9, 2014 with a preventive maintenance instruction to be performed on the device by user. Also included are the necessary tools to perform actions. Customers are to complete and return the Recall Response Card. Questions are to be directed to Customer Service. Contact Information: Customer Service: 1-800-891-1772 E-mail: RT-5100 [email protected]
Quantity in commerce: ~4,285 units RT-5100; 167 units of RT-3100
Distribution: US distribution only.
Product codes and lots: RT-5100 and RT-3100, various serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1853-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1853-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-23

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)