FDA-Device2017-03-29Class II
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.
Nidek Inc
Hazard
During treatment planning, the procedure was programmed with an unintended (wrong) correction.
Sold states
Nationwide Distribution to MN, NV, OH, NC, CA, CO, CA, GA, VA, MI, AZ, PA, TN, WA, TX, NY.
Affected count
29
Manufactured in
47651 Westinghouse Dr, Fremont, CA, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1494-2017Don't want to check this manually?
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