Nidek Inc
Fremont, CA
This page shows every FDA and USDA recall linked to Nidek Inc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
21
Total Recalls
2012
First Recall
2019
Most Recent
NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification i...
Feb 25, 2019
· Device
Terminated
RT-5100 Refractor, a component of the Epic-5100 System.
Jun 14, 2018
· Device
Terminated
AUTO REF/KERATOMETER ARK-1s
Dec 20, 2017
· Device
Terminated
Final Fit Software Version 1.11 and 1.12;
PC Based software installed outside Nidek EC-5000 Excimer Laser Sys...
Feb 1, 2017
· Device
Terminated
SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09.
Opthalmic: The NIDEK Specular Microscope CEM-530...
Sep 1, 2016
· Device
Terminated
OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier.
Ophthalmic: The OPTICAL BIOMETER AL-Scan is a m...
Jul 1, 2016
· Device
Terminated
RT-5100 (Epic 5100) Refractor and RT 3100 Refractor:
Product Usage:
Instrument providing means of positioning...
Mar 24, 2016
· Device
Terminated
OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic
Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1....
Aug 27, 2015
· Device
Terminated
Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System;
GYC4EP-01 0W02 and GYC4EP-...
Jul 14, 2015
· Device
Terminated
Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system
GYC4DD-1:
The Nidek Green Laser Photocoagu...
Jul 14, 2015
· Device
Terminated
EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest.
Opthalmic: NIDEK EXCIMER...
Jun 4, 2015
· Device
Terminated
YC-1800 OPHTHALMIC YAG LASER SYSTEM;
The YC-1800 allows the safe and bloodless treatment of intraocular
disea...
Apr 2, 2015
· Device
Terminated
MC-500 Multicolor Laser Photocoagulator;
Indicated for use in retinal photocoagulation for treatment of ocula...
Feb 19, 2015
· Device
Terminated
Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII.
Opthalmic Device. The system is composed as a...
Nov 17, 2014
· Device
Terminated
Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20.
Opthalmic Device. The Nidek Multico...
Nov 17, 2014
· Device
Terminated
MC-500 Multicolor Laser Photocoagulator using software version 2.20.
Opthalmic device used for retinal photoco...
Nov 17, 2014
· Device
Terminated
GYC-1000 Green Laser Photocoagulator system
The Nidek Green Laser Photocoagulator Model GYC -1000 is indicate...
Aug 13, 2014
· Device
Terminated
MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. F...
Jul 30, 2014
· Device
Terminated
Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the reti...
Jul 2, 2014
· Device
Terminated
RT-5100 Refractor and RT-3100 Refractor;
Distributed by MARCO Opthalmic:
Manufactured by NIDEK CO., Ltd., Aic...
Jun 23, 2014
· Device
Terminated
NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for us...
Aug 23, 2013
· Device
Terminated