Alcon’s Unity VCS and Unity CS Cleared by FDA

Alcon (SIX/NYSE: ALC), a global leader in eye care, has received U.S. FDA 510(k) clearance for its UNITY® Vitreoretinal Cataract System (VCS) and UNITY® Cataract System (CS). These advancements mark the debut of Alcon’s anticipated Unity portfolio.

“We have a longstanding commitment to collaborating with our customers throughout the R&D process to drive bold innovation in ophthalmology,” stated Franck Leveiller, Head of Global R&D and Chief Scientific Officer at Alcon. “We are thrilled to introduce these next-generation equipment solutions and consumables for cataract and vitreoretinal surgery, aiming to significantly benefit Eye Care Professionals and patients.”

Unity VCS and Unity CS bring enhanced workflow efficiencies compared to Alcon’s existing systems, including the CONSTELLATION® Vision System and CENTURION® Vision System with ACTIVE SENTRY®.

“I’ve been deeply involved in developing Unity VCS and Unity CS; this innovative system represents a major upgrade to Alcon’s best-in-class technologies,” said Steve Charles, MD, FACS, FICS, FASRS. “This clearance is a moment of pride for all involved.”

Globally, an estimated 31 million cataract surgeries are anticipated in 2024, with projections rising to 37 million by 2029. Additionally, there will be around 2.2 million vitrectomy procedures worldwide in 2024. Alcon holds a leading position in the global market for cataract and retina procedural packs.

Alcon plans to gather real-world feedback following the 510(k) clearance before the commercial launch in 2025, with regulatory submissions continuing globally later this year. The CE Mark is expected in early 2025.

Unity VCS and Unity CS are part of the Alcon Vision Suite, designed to enhance clinic and OR efficiency while providing exceptional patient experiences. Alcon plans to expand its Unity products in the coming years alongside its established market-leading offerings.

Cautionary Note Regarding Forward-Looking Statements:
This press release contains forward-looking statements subject to inherent uncertainties and risks. Actual results may differ materially from anticipated outcomes due to various factors discussed in Alcon’s filings with the United States Securities and Exchange Commission.

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