Nidek Inc: Medical Device Recall in 2015 - (Recall #: Z-1710-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 24, 2015

Date Posted: June 10, 2015

Recall Number: Z-1710-2015

Event ID: 71098

Reason for Recall:

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

Status: Terminated

Product Quantity: 114 units

Code Information:

Alll devices currently in use by consignees.

Distribution Pattern:

Us distribution only.

Voluntary or Mandated:

Voluntary: Firm initiated