Nidek Inc recalls Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophth…

Recall date

February 1, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1494-2017

FDA classification

Class II

Brand / firm

Nidek Inc

Sold / distributed

Nationwide Distribution to MN, NV, OH, NC, CA, CO, CA, GA, VA, MI, AZ, PA, TN, WA, TX, NY.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.