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Single-use lenses for RESIGHT, WIDE-ANGLE LENS

Carl Zeiss Meditec AG · Model 302721-9097-000 · UDI-DI 04049539106735

HRM Prescription

510(k) clearances

366

Adverse events

Recalls

Facilities

Description

Single- use lenses for RESIGHT are ophthalmic surgical microscope lenses used in combination with the ZEISS RESIGHT fundus viewing system. The fundus viewing system is an accessory for surgical microscopes which is used for surgery on the posterior segment of the eye. It is used for stereoscopic imaging of the posterior segment and the retina.

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.