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NIDEK CO.,LTD. · Model EC-5000 · UDI-DI 04987669100011

LZS Prescription

510(k) clearances

13,741

Adverse events (12 deaths)

Recalls

Facilities

Description

NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000CXIII, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system, and a computer for system control. The system is designed to be user friendly for easy and safe operation with NIDEK’s advanced optoelectronic technology.

Recalls

Date	Firm	Reason
2021-10-21	AMO Manufacturing USA, LLC	Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabled, and improperly p
2017-02-01	Nidek Inc	During treatment planning, the procedure was programmed with an unintended (wrong) correction.
2015-03-24	Nidek Inc	Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.
2013-09-16	Abbott Medical Optics, Inc.	This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the
2013-09-16	Abbott Medical Optics, Inc.	This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the
2013-09-16	Abbott Medical Optics, Inc.	This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the
2013-09-16	Abbott Medical Optics, Inc.	This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the
2013-05-28	Abbott Medical Optics, Inc.	Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
2013-05-28	Abbott Medical Optics, Inc.	Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
2013-05-28	Abbott Medical Optics, Inc.	Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.