FDA Clears Alcon's Unity Vitreoretinal-Cataract System and Unity Standalone Cataract System

FDA Clears Alcon's Unity Vitreoretinal-Cataract System and Unity Standalone Cataract System

June 25, 2024

Alcon has received FDA 510(k) clearance for its Unity Vitreoretinal Cataract System (VCS) and Unity Cataract System (CS), marking a significant advancement in surgical technology. These devices are the first offerings from Alcon's Unity portfolio, aimed at enhancing equipment solutions and consumables for cataract and vitreoretinal surgeries.

The Unity VCS and Unity CS promise improved workflow efficiencies compared to Alcon's current systems: the Constellation Vision System for vitreoretinal procedures and the Centurion Vision System with Active Sentry for cataract surgery.

"With over 28,000 Centurion and Constellation devices in circulation, transitioning to the Unity platform over the next decade is a strategic move," stated an Alcon spokesperson. The new systems integrate first-to-market technologies and consumables designed to deliver substantial benefits for surgeons, staff, and patients alike.

Extensive testing of the Unity VCS and Unity CS involved investigational advisory wet lab sessions with more than 200 surgeons from over 30 countries, ensuring robust performance and usability. Alcon plans to gather real-world feedback before the commercial launch scheduled for 2025. Regulatory submissions in various global markets are anticipated later this year, with CE Mark approval expected by early 2025.

The Unity VCS and Unity CS will join Alcon's Vision Suite portfolio and will be supported by comprehensive training, product maintenance, and services provided by Alcon's teams.

This clearance underscores Alcon's commitment to advancing surgical outcomes through innovative technology, setting a new standard in cataract and vitreoretinal surgery.

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