Z-0223-2015Class II

Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as...

Name: Z-0223-2015 Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as...
Creator: Nidek Inc
Published: 2012-08-06
License: https://open.fda.gov/license/

Nidek Incorporated / initiated 2012-08-06 / Terminated / root cause: design

FDA source

Nidek Inc began a recall of Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser generator which produces an excimer laser... on 2012-08-06. FDA classified it as Class II and gives the reason as "Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII Excimer Laser Corneal Surgery System that could cause a serious adverse event for the 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-0223-2015
Classification: Class II
Status: Terminated
Initiated: 2012-08-06
Posted: 2014-11-17
Terminated: 2014-11-17
Recalling firm: Nidek Incorporated
Product: Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.
Product code: LZS Excimer Laser System
Reason for recall: Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII Excimer Laser Corneal Surgery System that could cause a serious adverse event for the patient.
Root cause tag: design
FDA root cause: Component design/selection
Action: Nidek Engineers visited each site to perform correction - fuse holders have been inspected and replaced if necessary. An Engineering Change Order was issued on June 1, 2012, for inspection and/or replacement of affected fuse holders by Nidek Service Engineers. For further questions please call (510) 353-7785.
Quantity in commerce: 14 units
Distribution: US Distribution including the states of CO, NY, MO, LA, ME, CA, MI, AZ, CT and FL.
Product codes and lots: Serial numbers: 530054 530055 530070 530073 530078 530082 530086 530087 530098 530106 530121 530123 530150 530155

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0223-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0223-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-17

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)