Nidek Incorporated
The Colony, TX, US
NIDEK INCORPORATED appears in FDA device records in The Colony, TX. FDA records list one 510(k) clearance, 12 PMA records and one registered establishment. As of , FDA records show 21 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Nidek Incorporated carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Nidek, Inc.recall
510(k) clearance history
FDA records hold 1 510(k) clearance for Nidek Incorporated in 2011.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2936921 | 2936921 | NIDEK INCORPORATED | 6601 Cascades Court, The Colony, TX 75056 US | 2026 | and 15 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HJOBiomicroscope, Slit-Lamp, Ac-Powered
- JQPCalculator/Data Processing Module, For Clinical Use
- HKICamera, Ophthalmic, Ac-Powered
- HOXChart, Visual Acuity
- NFGDevice, Communications, Images, Ophthalmic
- NFFDevice, Storage, Images, Ophthalmic
- LZSExcimer Laser System
- HLMInstrument, Measuring, Lens, Ac-Powered
- HLQKeratoscope, Ac-Powered
- LXSLaser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
- LOILaser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
- HQFLaser, Ophthalmic
- NQEMicroscope, Specular
- MYCOphthalmoscope, Laser, Scanning
- HPTPerimeter, Automatic, Ac-Powered
- HQBPhotocoagulator And Accessories
- GEXPowered Laser Surgical Instrument
- HLGPupillometer, Ac-Powered
- HKORefractometer, Ophthalmic
- HKNRefractor, Manual, Non-Powered, Including Phoropter
- NFJSystem, Image Management, Ophthalmic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- HRJTable, Instrument, Powered, Ophthalmic
- OBOTomography, Optical Coherence
- HKXTonometer, Ac-Powered
- ITXTransducer, Ultrasonic, Diagnostic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0771-2020 | NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. | The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2) | Class III | Terminated | |
| Z-0655-2019 | RT-5100 Refractor, a component of the Epic-5100 System. | The lens bonding was incomplete on the refractor. | Class III | Terminated | |
| Z-1348-2018 | AUTO REF/KERATOMETER ARK-1s | There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s. | Class II | Terminated | |
| Z-1494-2017 | Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of 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. | During treatment planning, the procedure was programmed with an unintended (wrong) correction. | Class II | Terminated | |
| Z-2711-2016 | SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. | Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results feature that was not reviewed and approved by the FDA. | Class II | Terminated | |
| Z-2587-2016 | OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method. | Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement. | Class II | Terminated | |
| Z-1245-2016 | RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eye for purpose of determining refractive error and binocular functions. | There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refractor of the Near Point Chart Arm lowering spontaneously with potential for slight injury to face or nose of patient. | Class II | Terminated | |
| Z-2477-2015 | OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use for Mapping of refractive error distribution of the eye by measurement and analysis of spherical power, cylindrical power, and cylinder axis. | Software bug was found where there was no difference in Total and Corneal high-order aberrations, but differences were found in Internal high-order aberrations. | Class II | Terminated | |
| Z-2068-2015 | Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty. | Accessories to the GYC-1000 laser were missing Laser Aperture labels. | Class II | Terminated | |
| Z-2067-2015 | Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty. | Accessories to the GYC-1000 laser were missing Laser Aperture labels. | Class II | Terminated | |
| Z-1710-2015 | 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. | Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA. | Class II | Terminated | |
| Z-1367-2015 | YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless treatment of intraocular diseases for outpatients by mechanical disruption caused by energy of the YAG laser pulses. | Dear Doctor letter and Quick Reference Guide is being sent to users of the YC-1800 to reiterate important safety and cleaning information after complaints of pitting lens that may cause unclear images. | Class II | Terminated | |
| Z-1980-2014 | Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan. | Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image. | Class II | Terminated | |
| Z-2132-2014 | MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures. | Laser aperture label was not affixed to device prior to shipment in the US. | Class II | Terminated | |
| Z-1853-2014 | RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd., Aichi, Japan. Instrument provides means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subject's eyes for purpose of determining refractive error and binocular functions. | Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury. | Class II | Terminated | |
| Z-2120-2014 | GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty. | Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation, | Class II | Terminated | |
| Z-2046-2013 | NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images. | Under certain circumstances, the Left eye image may be saved as the Right eye image. | Class II | Terminated | |
| Z-0222-2015 | MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases. | Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required. | Class II | Terminated | |
| Z-0224-2015 | Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases. | When the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery unit occasionally fails to emit the laser, or the power output is lower than the set program. | Class II | Terminated | |
| Z-0223-2015 | 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. | 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. | Class II | Terminated | |
| Z-1127-2015 | MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment. | The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain