Nidek Recalls

Hazard: The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)

Hazard: The lens bonding was incomplete on the refractor.

Hazard: There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.

Hazard: During treatment planning, the procedure was programmed with an unintended (wrong) correction.

Hazard: 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.

Hazard: Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement.

Hazard: 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.

Hazard: 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.

Hazard: Accessories to the GYC-1000 laser were missing Laser Aperture labels.

Hazard: Accessories to the GYC-1000 laser were missing Laser Aperture labels.

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

Hazard: 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.

Hazard: The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.

Hazard: 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.

Hazard: 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.

Hazard: Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.

Hazard: Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation,

Hazard: Laser aperture label was not affixed to device prior to shipment in the US.

Hazard: Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.

Hazard: Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.

Hazard: Under certain circumstances, the Left eye image may be saved as the Right eye image.