Company: Nidek Inc
Date of Enforcement Report 3/29/2017
Class lI:
PRODUCT
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
Recall Number Z-1594-2017
REASON
During treatment planning, the procedure was programmed with an unintended (wrong) correction.
RECALLING FIRM/MANUFACTURER
Nidek Inc, Fremont, CA on 2/1/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
29
DISTRIBUTION
Nationwide Distribution to MN, NV, OH, NC, CA, CO, CA, GA, VA, MI, AZ, PA, TN, WA, TX, NY.
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