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Nidek Inc recalls EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER C
Recalled June 10, 2015 · FDA recall Z-1710-2015 · Nidek
Hazard
Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA. · FDA Class II
Units
114 units
Sold at
Us distribution only.
Description
Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.
Product
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.
Manufacturer(s)
Nidek Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →