Alcon Clareon Vivity IOL receives CE mark, European commercialisation announced

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Alcon announced that its Clareon Vivity lens received a CE Mark from the European Commission. In a press release, the company announced it will commence commercial rollout of the Clareon Vivity and Clareon Vivity Toric in early Q2 2025. The initial Q2 rollout will include Clareon Vivity lenses available with the Monarch IV manual delivery system, and beginning in Q3, the IOL will also be available as a preloaded lens with the AutonoMe system.¹

The Clareon Vivity is an extended depth-of-focus (EDOF) lens which provides presbyopia correction with a monofocal visual disturbance profile. Following this approval, all clinicians in countries which utilise the CE Mark now have access to the full Clareon line from Alcon, which also includes the Clareon Monofocal, Clareon Toric, Clareon PanOptix and Clareon PanOptix Toric.

Prof Ramin Khoramnia, MD, director of the University Eye Clinic in Dresden, Germany, said the approval reflects a growing need for specialised IOLs to meet the needs of a growing population. Over 10 million patients in Germany are currently impacted by cataracts, he said, and the Clareon Vivity provides a specialised option for patients with presbyopia.

"Due to advancements in cataract surgery and increased awareness of its safety and benefits, my practice has seen a growing number of middle-aged patients seeking early treatment," said Prof Khoramnia. “Many of these patients are still working, very active and want high-quality vision for both distance and intermediate tasks.”

Patients with retinopathy, maculopathy, glaucoma, dry eye disease and age-related macular degeneration can successfully receive presbyopia-correcting IOLs, and patient satisfaction is high among patients with other ocular comorbidities who receive the lenses, according to information from Alcon shared in the press release.

Sunil Vasanth, vice president of Alcon’s surgical franchise in Europe, said Clareon is the company’s “most advanced biomaterial” to date and ideally suited for patients with presbyopia. “When we created Vivity, our goal was to develop an innovative lens that would minimise patients' reliance on glasses and simplify presbyopia correction for surgeons,” he said. “We achieved this by designing a real EDOF lens, which has quickly become the world’s most implanted EDOF.”

According to the press release, the Clareon Vivity leverages a wavefront-shaping optical principal technology (X-Wave) to create a continuously extended focal range. Studies cited in the press release demonstrate the Clareon Vivity lens reduced spectacle dependence, improved intermediate and near vision and provided comparable distance vision when compared to an aspheric monofocal lens.The proprietary Clareon material has low levels of glare and posterior capsular opacification.²

The Clareon Monofocal, Clareon PanOptix, Clareon PanOptix Toric, Clareon Vivity and Clareon Vivity Toric IOLs launched in the United States in 2022.³

References

1. Alcon Announces CE Mark Approval and Commercialization of Clareon Vivity IOL in Europe, Expanding Visual Possibilities. Alcon. Press release. Published March 25, 2025. Accessed March 25, 2025. https://www.businesswire.com/news/home/20250324959798/en/Alcon-Announces-CE-Mark-Approval-and-Commercialization-of-Clareon-Vivity-IOL-in-Europe-Expanding-Visual-Possibilities

2. 2. Das KK, Werner L, Collins S, Hong X. In vitro and schematic model eye assessment of glare or positive dysphotopsia-type photic phenomena: Comparison of a new material IOL to other monofocal IOLs. J Cataract Refract Surg. 2019;45(2):219-227. doi:10.1016/j.jcrs.2018.09.017

3. Hutton D. Alcon launches new IOL in U.S.. Ophthalmology Times. Published March 7, 2022. Accessed March 25, 2025. https://www.ophthalmologytimes.com/view/alcon-launches-new-iol-in-u-s-