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Quest™

NIDEK CO.,LTD. · Model EC-5000 · UDI-DI 04987669100028

LZS Prescription

510(k) clearances

13,749

Adverse events (12 deaths)

Recalls

Facilities

Description

NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model Quest, 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.