Microscope, Operating & Accessories, Ac-Powered, Ophthalmic（HRM）

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 internal components, one specific component can fail which will cause the device to unexpectedly shutdown.

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 stop when releasing the button, result in potential risk to the patient's eye

The M220 optics may unintentionally drop into the surgical field, risking contact with the patient.

Potential for the optical head to detach from the stand due to the lack of thread adhesive.

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 proper on-screen display functionality of the HDR recording unit. Additionally, an anomaly in the device software may also lead to the unexpected behavior that when a user releases a handle or foot switch button this may not immediately end the actuated functionality. This behavior can only occur in unlikely workflows where a user changes a user profile or a mode change is initiated at the same time as a functional button is activated.

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.

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, host and illumination modules, potentially causing the system to display a system message, and/or resulting in illumination failure.