Alcon’s Clareon Vivity IOL gains CE Mark approval, expanding vision correction options in Europe

Alcon has secured CE Mark approval for Clareon Vivity intraocular lens (IOL), marking a significant step in the availability of advanced vision correction solutions across Europe. The approval paves the way for a commercial rollout beginning in early Q2 2025, with the Clareon Vivity Toric IOL and AutonoMe automated pre-loaded delivery system expected to follow in Q3 2025.

With this milestone, Alcon strengthens its presence in the extended depth of focus (EDOF) intraocular lens market, bringing its most advanced Clareon lens material to a broader patient base. The Clareon Vivity IOL is designed to provide presbyopia correction with enhanced clarity and predictable refractive outcomes, addressing the increasing demand for spectacle independence following cataract surgery.

How Does Clareon Vivity IOL Improve Vision After Cataract Surgery?

Cataracts remain the leading cause of vision impairment worldwide, affecting millions of people, particularly those over 60. Cataract surgery, one of the most common and successful medical procedures, involves replacing the eye’s clouded natural lens with an artificial intraocular lens (IOL). While traditional monofocal lenses restore clear distance vision, they often leave patients reliant on reading glasses for near and intermediate tasks.

The Clareon Vivity IOL addresses this limitation by incorporating X-WAVE Technology, an optical innovation that extends the range of vision by modifying the wavefront of light as it passes through the lens. This creates a continuous field of focus from distance to intermediate vision, reducing the need for additional corrective eyewear. Unlike multifocal lenses, which split light into different focal points, EDOF lenses like Clareon Vivity offer a more natural visual experience with fewer disruptions, such as halos and glare.

Why Is Clareon Vivity IOL a Game-Changer for Presbyopia Correction?

Presbyopia, the age-related loss of near vision, affects nearly all adults over 40. Traditional treatment options include reading glasses, contact lenses, or multifocal IOLs, but these solutions often come with compromises. Multifocal IOLs, for instance, rely on diffractive optics to create multiple focal points, sometimes leading to unwanted visual disturbances.

The Clareon Vivity IOL, by contrast, uses a non-diffractive EDOF design, allowing for seamless vision transitions across different distances. Patients can enjoy improved visual acuity for tasks such as reading menus, working on computers, and recognizing faces at arm’s length, all while maintaining crisp distance vision. The lens has been particularly well-received by active, working-age patients who desire greater freedom from glasses.

Clinical studies have shown that more than 90% of patients implanted with the Clareon Vivity IOL report high satisfaction, citing improved intermediate vision and reduced spectacle dependence compared to traditional monofocal IOLs. The technology also benefits those with mild ocular comorbidities such as glaucoma, dry eye disease, and age-related macular degeneration (AMD), expanding its applicability to a wider patient base.

How Does Clareon Lens Material Enhance Vision Quality?

The Clareon lens material represents a significant advancement in IOL technology, designed to deliver sharper, clearer vision with minimal optical imperfections. In comparison to older hydrophobic acrylic IOLs, Clareon lenses exhibit exceptionally low levels of haze and glistenings, which can degrade vision over time.

Glistenings, microscopic fluid-filled inclusions that develop within IOLs, have long been a concern for ophthalmic surgeons due to their potential impact on visual clarity. Alcon’s Clareon material has been engineered to minimize these artifacts, ensuring long-term transparency and stable optical performance.

Additionally, Clareon Vivity IOL is designed with STABLEFORCE Haptics, which provide axial and rotational stability after implantation. This feature is particularly beneficial for patients requiring Clareon Vivity Toric IOL, as precise alignment is critical for correcting astigmatism.

What Does CE Mark Approval Mean for European Surgeons and Patients?

Gaining CE Mark approval allows Alcon to market and distribute Clareon Vivity IOL and Clareon Vivity Toric IOL across European Economic Area (EEA) countries. This regulatory clearance is a key milestone, as the region represents a significant market for premium IOLs, given its aging population and increasing demand for presbyopia correction technologies.

The commercial rollout will provide European ophthalmic surgeons with access to Alcon’s full range of Clareon IOLs, which also includes Clareon Monofocal, Clareon Toric, Clareon PanOptix, and Clareon PanOptix Toric. With this expanded portfolio, surgeons can better tailor lens selection to individual patient needs, offering a broader spectrum of vision correction solutions.

How Will Alcon’s Clareon Vivity IOL Impact the Premium IOL Market?

Alcon’s introduction of the Clareon Vivity IOL into the European market is expected to strengthen its competitive position within the premium IOL segment. The company, which trades on the New York Stock Exchange (NYSE: ALC) and SIX Swiss Exchange, has consistently expanded its surgical and vision care divisions, with IOL sales playing a pivotal role in its revenue growth.

The demand for presbyopia-correcting IOLs has surged in recent years, driven by advancements in cataract surgery techniques, patient awareness, and increasing expectations for spectacle-free vision. As the only non-diffractive EDOF lens available on Alcon’s Clareon material, the Clareon Vivity IOL is positioned as a key differentiator in the competitive ophthalmic market.

With CE Mark approval secured, Alcon’s European launch strategy will focus on surgeon education, clinical training, and seamless integration of Clareon Vivity IOL into existing surgical workflows. The upcoming AutonoMe automated pre-loaded delivery system, scheduled for release in Q3 2025, is expected to further enhance adoption rates by offering a streamlined implantation process.

What’s Next for Clareon Vivity IOL?

The launch of Clareon Vivity IOL in Europe marks a significant milestone in Alcon’s efforts to bring next-generation presbyopia correction technology to a global audience. As ophthalmic research continues to evolve, the demand for premium IOLs with extended depth of focus capabilities is expected to rise, shaping the future of cataract surgery and refractive lens exchange.

With strong clinical backing, high patient satisfaction, and regulatory clearance in one of the world’s most advanced healthcare markets, Clareon Vivity IOL is poised to redefine the standard for presbyopia correction, offering patients greater visual freedom while supporting surgeons in delivering superior outcomes.