Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2068-2015·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as missing labels without reporting any injuries, illnesses, or specific functional hazards, aligning with the rubric for minor labeling errors.

Plain-English summary

Nidek Inc is recalling specific accessories for the GYC-1000 Green Laser Photocoagulator System. The affected items are the Endophotocoagulation Delivery 4EP-1, specifically model numbers GYC4EP-01 0W02 and GYC4EP-1 0Z20. The recall is due to the absence of required Laser Aperture labels on these accessories.

The affected units were distributed in the United States to the states of California, Illinois, Minnesota, Missouri, Oregon, Utah, Rhode Island, Massachusetts, Washington, Nebraska, New York, New Jersey, Texas, and Wisconsin. The recall involves one unit of model GYC4EP-01 0W02 and six units of model GYC4EP-1 0Z20.

The GYC-1000 system is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy, and trabeculoplasty. Users of these specific accessories should contact Nidek Inc for further instructions regarding the missing labels.

The recalled product

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…
Manufacturer: Nidek Inc
Category: Medical Device — Ophthalmic Surgical Equipment
Hazard: mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Model GYC4EP-01 0W02 and GYC4EP-1 0Z20

Distribution

Distributed in 14 states:

Part of a larger recall action

This product is one of 2 recalled by Nidek Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Nidek Inc

See all →

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High
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FDA (Devices) · 2017-03-29
Moderate
Nidek Specular Microscope CEM-530 Software Recall for Unapproved Feature
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Same hazard · mis labeling