EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER CORN

FDA device recall Z-1710-2015 · posted 2015-06-04 · Terminated

Recall details

Recalling firm

Nidek Inc

Reason for recall

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

Action taken

Nidek sent an Device Correction letter dated April 30th, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Nidek will contact customers to schedule an appointment to replace the operators manual and implementing a software lockout device on the device so that the multi stage feature is no longer available. If a Nidek rep does not contact you before April 30, 2015, please call 800-223-9044 to schedule an appointment, All non responding customers.will be contacted three time via Fed Ex letter

Root cause

No Marketing Application

Status

Terminated

Product code

LZS

Quantity affected

114 units

Distribution

Us distribution only.

Date initiated

2015-03-24

Date posted

2015-06-04

Date terminated

2016-04-05

Location

Fremont, CA