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ARTEVO 800

Carl Zeiss Meditec AG · Model 6647 · UDI-DI 04049539066473

HRM Prescription

510(k) clearances

366

Adverse events

Recalls

Facilities

Recalls

Date	Firm	Reason
2022-11-21	Leica Microsystems, Inc.	There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the int
2020-11-20	Haag-Streit USA Inc	Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button of the footswitch it might occur that the movement does not s
2019-01-02	Leica Microsystems, Inc.	The M220 optics may unintentionally drop into the surgical field, risking contact with the patient.
2018-07-17	Alcon Research Laboratories Ltd.	Potential for the optical head to detach from the stand due to the lack of thread adhesive.
2017-09-25	Leica Microsystems, Inc.	The observed issues can lead to unexpected interruptions of the optics carrier focus drive movement, intermittent stops of the X-Y coupling movement or sporadic failures in the pro
2017-05-25	Alcon Research, Ltd.	Multiple shipments or forceful impact to a caster on a LuxOr/LX3 microscope may stress the microscope base, which could contribute to a caster breaking or detaching from the base.
2015-08-11	Alcon Research, Ltd.	Alcon is initiating a voluntary recall of all LX3 Microscope Floor Stands after receiving reports concerning loss of functionality due to issues with the cabling between the power,

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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.