Nidek Inc recalls EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER COR…

Recall date

March 24, 2015

Source

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

Recall number

Z-1710-2015

FDA classification

Class II

Brand / firm

Nidek Inc

Sold / distributed

Us distribution only.

Why it was recalled

Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.

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

What was recalled

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.