Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System Recalled by Nidek Inc Due to Accessories to the GYC-1000 laser were missing Laser...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Nidek Inc directly.
Affected Products
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.
Quantity: W020 - 1 unit; 0Z20- 6 units
Why Was This Recalled?
Accessories to the GYC-1000 laser were missing Laser Aperture labels.
Where Was This Sold?
This product was distributed to 14 states: CA, IL, MA, MN, MO, NE, NJ, NY, OR, RI, TX, UT, WA, WI
About Nidek Inc
Nidek Inc has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report