Recall Z-1710-2015— Nidek Inc

Name: FDA recall Z-1710-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-24

Class II · Terminated

Class II FDA medical device recall by Nidek Inc, initiated 2015-03-24, terminated 2016-04-05. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA..

Recalling firm: Nidek Inc
Classification: Class II
Status: Terminated
Initiated: 2015-03-24
Terminated: 2016-04-05
Firm location: Fremont, CA, United States

Product description

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.

Reason for recall

Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.

Data sourced from openFDA. This site is unofficial and independent of the FDA.