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Terminated

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.

FDA Recall Z-1710-2015 · Posted 2015-06-04

Recalling FirmNidek Inc
Recall StatusTerminated
Product CodeLZS
Date Initiated2015-03-24
Date Terminated2016-04-05
Product Quantity114 units

Reason for Recall

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

Firm Action

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

Distribution Pattern

Us distribution only.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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