Monday, July 15, 2024

U.S. FDA 510(k) Clearance Granted to Alcon’s Newest Equipment Technologies, Unity VCS and Unity CS

Alcon Announces FDA Clearance of Unity Vitreoretinal Cataract System and Unity Cataract System

Alcon Receives FDA Clearance for Innovative Unity Surgical Systems

Alcon, the global leader in eye care, has just received FDA clearance for its groundbreaking UNITY Vitreoretinal Cataract System (VCS) and UNITY Cataract System (CS). These new systems are the first to be introduced from Alcon’s cutting-edge Unity portfolio, featuring advanced technologies designed to revolutionize surgical innovation.

The UNITY VCS and UNITY CS are set to deliver significant workflow efficiencies over Alcon’s current market-leading systems, promising a new era of equipment solutions and consumables for eye care professionals and patients alike.

“We are thrilled to bring the next generation of surgical equipment to the market, thanks to the dedication and collaboration of our customers and research teams,” said Franck Leveiller, Head of Global R&D and Chief Scientific Officer at Alcon. “With UNITY VCS and UNITY CS, we are proud to offer transformative technologies that will enhance the surgical experience for all stakeholders.”

Notable ophthalmologist, Dr. Steve Charles, expressed his excitement about the clearance, stating, “The Unity VCS and Unity CS represent a major leap forward in surgical technologies, and I am honored to be part of this significant milestone.”

With an estimated 31 million cataract surgeries and 2.2 million vitrectomy procedures expected globally in 2024, the demand for innovative surgical solutions is higher than ever. Alcon’s UNITY systems are poised to meet and exceed these needs, with plans to upgrade over 28,000 existing devices to the Unity platform in the coming years.

To ensure the seamless integration and effectiveness of UNITY VCS and UNITY CS, Alcon will be collecting real-world user feedback before the full commercial launch in 2025. With continued development and regulatory submissions scheduled, Alcon aims to expand its market reach and uphold its commitment to delivering exceptional eye care solutions.

For more information about Alcon and the UNITY VCS and UNITY CS systems, visit With a legacy of over 75 years in eye care, Alcon continues to lead the way in enhancing sight and improving lives through innovation and excellence in surgical solutions.

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