RegWardenFDA facility compliance records
Company

NIDEK CO., LTD.

20 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2012: 3 recalls; 2013: 2 recalls; 2014: 4 recalls; 2015: 4 recalls; 2016: 3 recalls; 2017: 2 recalls; 2018: 1 recalls; 2019: 1 recalls3’122’134’144’153’162’171’181’19’20’21’22’23’24’25’26
  • Recalls (20)

Registered facilities (2)

Recalls & enforcement

20191 record
  • Class IIITerminated2019-02-25
    The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)
20181 record
20172 records
  • Class IITerminated2017-12-20
    There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.
  • Class IITerminated2017-02-01
    During treatment planning, the procedure was programmed with an unintended (wrong) correction.
20163 records
  • Class IITerminated2016-08-08
    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 IITerminated2016-07-01
    Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement.
  • Class IITerminated2016-02-29
    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.
20154 records
  • Class IITerminated2015-06-15
    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 IITerminated2015-03-25
    Accessories to the GYC-1000 laser were missing Laser Aperture labels.
  • Class IITerminated2015-03-24
    Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.
  • Class IITerminated2015-03-06
    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.
20144 records
20132 records
  • Class IITerminated2013-08-01
    Under certain circumstances, the Left eye image may be saved as the Right eye image.
  • Class IITerminated2013-05-24
    Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.
20123 records
  • Class IITerminated2012-10-24
    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 IITerminated2012-08-06
    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 IITerminated2012-03-27
    The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “NIDEK CO., LTD. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-8030392-nidek-co-ltd/

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