Alcon obtains FDA 510(k) approval for Unity VCS and CS systems

The Unity Vitreoretinal Cataract System (VCS) and Unity Cataract System (CS) are expected to enhance workflow efficiencies, surpassing Alcon's current systems.

Archana Rani June 24 2024

Alcon has secured US Food and Drug Administration (FDA) 510(k) clearance for its Unity VCS and Unity CS.

These systems are part of Alcon's Unity portfolio and mark the latest innovations from the Alcon Vision Suite, a product portfolio designed to enhance clinic and operating room efficiency for eye care professionals.

When used with compatible devices, the Unity VCS console is intended for use during anterior and posterior segments ophthalmic surgery.

The Unity CS console is intended for use during anterior segment ophthalmic surgery.

The Unity VCS and Unity CS are set to enhance workflow efficiencies, surpassing Alcon's current systems, the Constellation Vision System used for vitreoretinal procedures and the Centurion Vision System with Active Sentry for cataract surgery.

With more than 28,000 Centurion and Constellation devices currently available in the market, Alcon aims to upgrade these to the Unity platform over the next ten years.

Furthermore, the systems introduce first-to-market technologies and consumables to offer substantial benefits, not only for surgeons but also for their staff and patients.

Alcon chief scientific officer and Global R&D head Franck Leveiller said: “At Alcon, we have a long legacy of involving our customers throughout the research and development process to deliver bold innovation in ophthalmology, and we would like to thank those who helped us arrive at today’s milestone.

“We are excited to introduce the next generation of equipment solutions and consumables – in cataract and vitreoretinal surgery – and deliver meaningful impact for eye care professionals and patients.”

Alcon is planning to commence a comprehensive programme to gather real-world feedback prior to the commercial launch anticipated in 2025.

The company will continue to submit regulatory filings globally throughout the year, with the expectation of receiving the CE Mark in early 2025.

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