Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EC-5000 Excimer Laser Corneal Surgery System (EC-5000 Recalled by Nidek Inc Due to Multi-stage treatment option for the EC-5000 Operator's Manual...
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
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.
Quantity: 114 units
Why Was This Recalled?
Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.
Where Was This Sold?
Us distribution only.
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