Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Final Fit Software Version 1.11 and 1.12 Recalled by Nidek Inc Due to During treatment planning, the procedure was programmed with...
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
Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.
Quantity: 29
Why Was This Recalled?
During treatment planning, the procedure was programmed with an unintended (wrong) correction.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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