Z-1710-2015Class II

EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER...

Name: Z-1710-2015 EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER...
Creator: Nidek Inc
Published: 2015-03-24
License: https://open.fda.gov/license/

Nidek Incorporated / initiated 2015-03-24 / Terminated

FDA source

Nidek Inc began a recall of EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000, is... on 2015-03-24. FDA classified it as Class II and gives the reason as "Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1710-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-24
Posted: 2015-06-04
Terminated: 2016-04-05
Recalling firm: Nidek Incorporated
Product: EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface.
Product code: LZS Excimer Laser System
Reason for recall: Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.
FDA root cause: No Marketing Application
Action: Nidek sent an Device Correction letter dated April 30th, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Nidek will contact customers to schedule an appointment to replace the operators manual and implementing a software lockout device on the device so that the multi stage feature is no longer available. If a Nidek rep does not contact you before April 30, 2015, please call 800-223-9044 to schedule an appointment, All non responding customers.will be contacted three time via Fed Ex letter
Quantity in commerce: 114 units
Distribution: Us distribution only.
Product codes and lots: Alll devices currently in use by consignees.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1710-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1710-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-10	2015-06-04

Product code LZS

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)