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Cassini Guidance System

Cassini Technologies B.V. · Model 1.0.0 · UDI-DI 08720892096401

NFG Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Cassini Guidance System provides guidance assistance to the surgeon during eye surgeries. The device displays real-time non-diagnostic video during eye surgery on a flat panel display device positioned for live visualization by the surgeon and surgical personnel in the operating room. The Cassini Guidance System provides graphical tools to the surgeon as desired during treatment by using pre-operative clinical data and surgeon-driven, onscreen templates and tools. The system utilizes surgeon confirmation at each step to plan and position guidance tools. The system neither performs any interpretations nor provides treatment recommendations.

Recalls

Date	Firm	Reason
2016-03-01	Alcon Research, Ltd.	Alcon is conducting a voluntary medical device correction of all VERION Reference Units (Vision Planner) that are shared with the Alcon LenSx Laser System after receiving reports c

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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.