The Recall Desk

Manufacturer

Nidek, Inc.

21 recalls in our database name Nidek, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
21
Critical
0
Severe
1
Most recent
2020-01-08

Of the 21 recalls from Nidek, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (5%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–21 of 21

  • LowFDA (Devices)·Z-0771-2020·2020-01-08

    Nidek Specular Microscope Recalled for Electromagnetic Noise Exceeding Standards

    Nidek, Inc. is recalling 13 Specular Microscopes, Model CEM-530, because their electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard.

    Product
    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 analy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0655-2019·2018-12-26

    Nidek RT-5100 Refractor Recalled for Incomplete Lens Bonding

    Nidek Inc. is recalling 85 RT-5100 Refractors distributed in Florida because the lens bonding was incomplete.

    Product
    RT-5100 Refractor, a component of the Epic-5100 System.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1494-2017·2017-03-29

    Nidek EC-5000 Excimer Laser Software Recall for Unintended Correction Programming

    Nidek Inc is recalling Final Fit Software versions 1.11 and 1.12 for the EC-5000 Excimer Laser System because treatment planning could be programmed with an unintended correction.

    Product
    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 produce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2711-2016·2016-09-07

    Nidek Specular Microscope CEM-530 Software Recall for Unapproved Feature

    Nidek Inc is recalling 29 Specular Microscope CEM-530 units because software versions 1.08 and 1.09 include an unapproved analysis feature.

    Product
    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 endothelia
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2587-2016·2016-08-24

    Nidek Optical Biometer AL-Scan Recalled for Inaccurate Axial Length Measurements

    Nidek Inc. is recalling 17 Optical Biometer AL-Scan devices because they measured axial lengths as much shorter than actual values.

    Product
    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 rad
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1245-2016·2016-03-30

    Nidek RT-5100 and RT-3100 Refractors Recalled for Arm Malfunction

    Nidek Inc is recalling RT-5100 and RT-3100 refractors because the Near Point Chart Arm may lower spontaneously, posing a risk of slight injury to the patient's face or nose.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2477-2015·2015-09-02

    Nidek OPD-Scan III Recall for Software Aberration Calculation Error

    Nidek Inc is recalling 3,836 OPD-Scan III Refractive Power/Corneal Analyzers due to a software bug that incorrectly calculates high-order aberrations.

    Product
    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 f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2068-2015·2015-07-22

    Nidek GYC-1000 Laser Accessories Recalled for Missing Labels

    Nidek Inc is recalling GYC-1000 laser accessories because they are missing Laser Aperture labels. The affected units were distributed to 13 US states.

    Product
    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,
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-2067-2015·2015-07-22

    Nidek Green Laser Photocoagulator Accessories Recalled for Missing Labels

    Nidek Inc is recalling 22 units of GYC-1000 laser accessories because they are missing required Laser Aperture labels.

    Product
    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.
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1710-2015·2015-06-10

    Nidek EC-5000 Excimer Laser System Recalled for Unapproved Manual Feature

    Nidek Inc is recalling 114 EC-5000 Excimer Laser Corneal Surgery Systems because the multi-stage treatment option in the operator's manual was not approved by the FDA.

    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.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1367-2015·2015-04-08

    Nidek YC-1800 Ophthalmic YAG Laser System Recalled for Pitting Lens

    Nidek Inc is recalling 799 YC-1800 Ophthalmic YAG Laser Systems due to complaints of pitting lenses that may cause unclear images.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1127-2015·2015-02-25

    Nidek MC-500 Laser Photocoagulator Recalled for Spot Size Control Defect

    Nidek Inc is recalling 16 MC-500 Multicolor Laser Photocoagulators because the spot size control may turn by itself, posing a risk of unintended laser delivery.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0223-2015·2014-11-26

    Nidek Excimer Laser System Recalled Due to Fuse Holder Contact Failure

    Nidek Inc is recalling 14 EC-5000 CXIII Excimer Laser Corneal Surgery Systems because a contact failure in fuse holders could cause serious adverse events for patients.

    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
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0224-2015·2014-11-26

    Nidek MC-500 Laser Photocoagulator Recalled for Power Output Failure

    Nidek Inc is recalling 21 MC-500 Multicolor Laser Photocoagulators because the devices may fail to emit laser light or output lower power than programmed during retinal treatment.

    Product
    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.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0222-2015·2014-11-26

    Nidek MC-500 Laser Photocoagulator Recalled for Unreported Engineering Change

    Nidek Inc is recalling five MC-500 Multicolor Laser Photocoagulators because an engineering change order regarding a memory function problem was not reported as required.

    Product
    MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-2120-2014·2014-08-20

    Nidek GYC-1000 Green Laser Photocoagulator Recalled for Missing Aperture Label

    Nidek Inc is recalling 567 GYC-1000 Green Laser Photocoagulator systems because the required laser aperture label was not applied to the devices.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2132-2014·2014-08-06

    Nidek MC-500 Laser Photocoagulator Recalled for Missing Aperture Label

    Nidek Inc. is recalling 29 MC-500 Multicolor Laser Photocoagulators because the laser aperture label was not affixed to the devices prior to shipment.

    Product
    MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1980-2014·2014-07-09

    Nidek AFC-330 Fundus Camera Recalled for Image Defects

    Nidek Inc. is recalling 185 AFC-330 Non-Mydriatic Auto Fundus Cameras because images may contain white spots that could affect diagnosis.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1853-2014·2014-07-02

    Nidek RT-5100 and RT-3100 Refractors Recalled for Potential Injury

    Nidek Inc is recalling RT-5100 and RT-3100 refractors because the near point chart arm may lower spontaneously, posing a risk of patient injury.

    Product
    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 d
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2046-2013·2013-09-04

    Nidek NAVIS-EX Image Filing Software Recalled for Eye Image Mislabeling

    Nidek Inc is recalling NAVIS-EX software because left eye images may be incorrectly saved as right eye images.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Nidek

business

Country
Japan
Founded
1971

Official website

Source: Wikidata (Q11324560), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.