Z-0655-2019Class III

RT-5100 Refractor, a component of the Epic-5100 System

Name: Z-0655-2019 RT-5100 Refractor, a component of the Epic-5100 System
Creator: Nidek Inc.
Published: 2018-06-14
License: https://open.fda.gov/license/

Nidek Incorporated / initiated 2018-06-14 / Terminated / root cause: manufacturing process

FDA source

Nidek Inc. began a recall of RT-5100 Refractor, a component of the Epic-5100 System on 2018-06-14. FDA classified it as Class III and gives the reason as "The lens bonding was incomplete on the refractor". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0655-2019
Classification: Class III
Status: Terminated
Initiated: 2018-06-14
Posted: 2018-12-21
Terminated: 2020-06-03
Recalling firm: Nidek Incorporated
Product: RT-5100 Refractor, a component of the Epic-5100 System.
Product code: HKN Refractor, Manual, Non-Powered, Including Phoropter
Reason for recall: The lens bonding was incomplete on the refractor.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The recalling firm called the sole distributor on 6/14/2018 to determine the quantity of instruments still in their control. During the phone call, the distributor was also notified of the invoice numbers that show the serial numbers involved, was asked to segregate the affected product, and a schedule was discussed for the recalling firm's technicians to visit the distributor for correction of the product.
Quantity in commerce: 85 instruments
Distribution: Distribution was made to FL.
Product codes and lots: Serial numbers 921042, 921043, 921044, 921045, 921046, 921047, 921048, 921049, 921050, 921051, 921052, 921053, 921054, 921055, 921056, 921057, 921058, 921059, 921060, 921061, 921062, 921063, 921064, 921065, 921066, 921067, 921068, 921069, 921070, 921071, 921072, 921073, 921074, 921075, 921076, 921077, 921078, 921079, 921080, 921081, 921084, 921085, 921086, 921087, 921088, 921089, 921090, 921091, 921092, 921093, 921094, 921095, 921096, 921097, 921098, 921099, 921100, 921101, 921102, 921103, 150028, 150029, 150030, 150031, 150032, 150033, 150034, 150035, 150036, 150037, 150038, 150039, 150040, 150041, 150042, 150043, 150044, 150045, 150046, 150047, 150048, 150049, 150050, 150051, and 150052

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0655-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0655-2019	Class III	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-20

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)