- Clareon Vivity IOL provides an extended range of vision from
distance to functional near with a monofocal visual disturbance
profile1-3µ‖
- Vivity, the world’s leading EDOF, is now available on
Alcon’s Clareon material, providing presbyopia correction with
exceptional† clarity and predictable refractive
outcomes1,4-7
- CE Marked countries will begin commercial rollout of Clareon
Vivity and Clareon Vivity Toric from early Q2 2025; also available
in AutonoMe automated pre-loaded delivery system in Q3
20258
Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated
to helping people see brilliantly, today announced that Vivity®,
the most widely implanted9 extended depth of focus (EDOF)
intraocular lens (IOL), is now available on Alcon’s most advanced
lens material—Clareon®.1 Clareon Vivity® received CE Mark and will
commence commercial rollout in Europe from early Q2 2025.
"Cataracts are the most common cause of vision loss globally10,
and in Germany alone, 10 million patients are affected by
cataracts.11 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. Dr. Ramin Khoramnia, Director of the University Eye
Clinic in Dresden. "Many of these patients are still working, very
active, and want high-quality vision for both distance and
intermediate tasks. With Clareon Vivity, I can provide my patients
a presbyopia-correcting IOL, significantly reducing their need for
glasses.12”
Vivity’s compelling real-world outcomes demonstrate that
patients with certain mild comorbidities—such as age-related
macular degeneration (AMD), retinopathy/maculopathy, glaucoma, and
dry eye—as well as those with post-refractive eyes, can
successfully receive presbyopia-correcting IOLs. The study further
reported high patient satisfaction rates of over 90% across these
diverse eye condition groups.12
"Clareon Vivity will broaden my presbyopia correction offering
to more patients, including those with ocular comorbidities like
glaucoma, age-related macular degeneration (AMD), or dry eyes.13
Clareon Vivity’s broad range of dioptres and cylinders will help me
address mild, moderate and high refractive error patients with a
PCIOL,1” said Dr. Mercè Guarro, CEO Instituto de Oftalmologia
Médica y Quirúrgica OMIQ & Head of Ophthalmology Department at
Hospital Granollers. “Clareon Vivity is an excellent lens option
that improves vision with a visual disturbance profile of a
monofocal IOL, giving my patients the freedom to engage in
activities they love, both during the day and at night.”
Clareon is a pristine material with one of the lowest levels of
haze and glistenings*† compared to leading competitor IOLs, marking
a significant advancement for surgeons and patients. 7,14,15
Clareon offers sharp, crisp vision with a proprietary edge designed
to help reduce glare and posterior capsular opacification.6 The
lens’ unique and proven STABLEFORCE® Haptics provide excellent
axial and rotational stability.5‡
“When we created Vivity, our goal was to develop an innovative
lens that would minimize patients' reliance on glasses and simplify
presbyopia correction for surgeons. We achieved this by designing a
real EDOF lens, which has quickly become the world’s most implanted
EDOF. This lens is now available in our most advanced biomaterial
to date, Clareon,1” said Sunil Vasanth, Vice President Surgical
Franchise, Europe.
Clareon Vivity leverages a wavefront-shaping optical principle,
trademarked as X-WAVE™ Technology, and uses proprietary transition
elements to create advanced and delayed wavefronts, resulting in a
continuously extended focal range.1-3µ‖ When compared to an
aspheric monofocal, Clareon Vivity reduced spectacle dependence,
provided comparable distance vision, and improved intermediate and
near vision while maintaining overall mesopic contrast sensitivity.
About 90% of the Vivity patients are highly satisfied with their
visual outcomes and would choose a Vivity IOL again, and more than
9 in 10 patients said they would recommend Vivity to their friends
and family.12
Now with the CE Mark of Clareon Vivity and Clareon Vivity Toric,
surgeons in Europe have access to the full range of Clareon IOLs to
meet the diverse needs of their patients, including Clareon
Monofocal, Clareon Toric, Clareon PanOptix® and Clareon PanOptix
Toric – all available in ultraviolet absorbing and blue light
filtering foldable options.1,16,17 Clareon Vivity is inserted using
Clareon Monarch® IV, an easy-to-use, reusable manual delivery
system, and is also available in the AutonoMe® Automated Pre-Loaded
Delivery System.8,18
For more information about Clareon Vivity and Clareon Vivity
Toric, please visit MyAlcon.com or speak to your sales
representative within Europe.
About Cataracts
A cataract is a cloudy area in the natural lens of the eye that
affects vision. As a cataract develops, the eye's lens gradually
becomes hard and cloudy, allowing less light to pass through, which
makes it more difficult to see. Most cataracts result from normal
aging, but radiation exposure, steroid use, diabetes and eye trauma
can accelerate their development.10,19 Cataracts are the most
common age-related eye condition and the leading cause of
preventable blindness.20 Cataracts are treated by removing the
eye's cloudy natural lens and surgically replacing it with an
intraocular lens (IOL). More than 92% of cataract surgeries are
considered successful, and patients typically return to their
normal routines within 24 hours.19,21
About Vivity
The non-diffractive Clareon Vivity Extended Vision Hydrophobic
Posterior Chamber IOLs (referred to as Clareon Vivity) and AcrySof
IQ Vivity Extended Vision Posterior Chamber Intraocular Lens Model
DFT015 (referred to as AcrySof IQ Vivity IOL) are UV-absorbing and
blue-light-filtering foldable intraocular lenses (IOLs). Vivity IOL
provides an extended range of vision from distance to near, with
low levels of visual disturbances.
Potential side effects: As with any surgery, there is an
implicit risk, whether or not the IOL is implanted. The
complications of the IOL implantation surgery ranges from minor
side effects (usually temporary) to serious complications.1
Patients with previous illnesses or disorders (such as chronic
infections of the eye or eyelids, or diabetes) may present a higher
risk of complications. Temporary surgical complications include,
but are not limited to, reactions to medications such as irritation
or mild allergic response, bleeding, redness, itching of the eye,
sensitivity to light, swelling, corneal edema (swelling of the
cornea), problems with the iris, cell growth in the IOL, and an
increase temporary eye pressure. There is a small risk of needing
further surgical treatment after the implantation of the initial
IOL.1
Careful preoperative evaluation and sound clinical judgment
should be used by the surgeon to decide the benefit/risk ratio
before implanting a lens in a patient with ocular comorbidities as
indicated in the IFU.
About Alcon
Alcon helps people see brilliantly. As the global leader in eye
care with a heritage spanning over 75 years, we offer the broadest
portfolio of products to enhance sight and improve people’s lives.
Our Surgical and Vision Care products touch the lives of more than
260 million people in over 140 countries each year living with
conditions like cataracts, glaucoma, retinal diseases and
refractive errors. Our more than 25,000 associates are enhancing
the quality of life through innovative products, partnerships with
Eye Care Professionals and programs that advance access to quality
eye care. Learn more at www.alcon.com.
µ Results from a prospective, randomized, parallel group,
subject- and assessor-masked, multisite trial of 107 subjects
bilaterally implanted with the AcrySof® IQ Vivity® IOL and 113 with
the AcrySof® IQ IOL with 6 months follow-up.
‖ AcrySof® IQ Vivity® was tested. Clinical studies were
performed on the AcrySof® IQ Vivity® IOL; AcrySof® IQ Vivity® and
Clareon® Vivity® are optically equivalent.
Response to the following question in IOLSAT questionnaire at 6
months post-op (AcrySof® IQ Vivity® IOL, n=106; monofocal, n=111):
“Given your vision today, would you have the same lenses implanted
again?”
* Glistening-free is defined as modified Miyata grade 0,
<25mv/mm2
† Based on in vitro examinations of glistenings, surface haze
and SSNGs; as compared to Clareon® CNA0T0, TECNIS§ ZCB00, TECNIS§
OptiBlue, Eternity§ W-60 and enVista§ MX60; n=30 per group;
p<.001
‡ Both AcrySof® and Clareon® are designed with STABLEFORCE®
Haptics
§ Trademarks are the property of their respective owners.
References
- Clareon® Vivity® Extended Vision Hydrophobic IOL CE Mark –
DFU.
- Alcon Data on File. US Patent 9968440 B2. 15 May 2018.
- Bala C, et al. Multi-country clinical outcomes of a new
nondiffractive presbyopia-correcting intraocular lens. J Cataract
Refract Surg. 2022;48(2):136-143.
- Werner L, Thatthamla I, Ong M, et al. Evaluation of clarity
characteristics in a new hydrophobic acrylic IOL in comparison to
commercially available IOLs. J Cataract Refract Surg.
2019;45(10):1490-1497. doi:10.1016/j.jcrs.2019.05.017.
- Lane S, et al. Evaluation of intraocular lens mechanical
stability. J Cataract Refract Surg. 2019;45:501-506.
- Das KK, et al. In vitro and schematism 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. Epub 2018 Nov
22. PMID: 30471850.
- Oshika T, Fujita Y, Inamura M, Miyata K. Mid-term and long-term
clinical assessments of a new 1-piece hydrophobic acrylic IOL with
hydroxyethyl methacrylate. J Cataract Refract Surg.
2020;46(5):682-687.
- Clareon® Vivity® Extended Vision Hydrophobic IOL with the
AutonoMe® – CE Mark Directions for Use.
- Alcon Data on File, 2024.
- World Health Organization. Cataract. Available at:
https://www.emro.who.int/health-topics/cataract/. Accessed:
September 2022.
- Strohlein LM. Cataracts When vision becomes cloudy.
Informationsdienst Wissenschaft (idw). January 8, 2019. Accessed
June 13, 2023. https://idw-online.de/de/news720054.
- Alcon Research LLC. Data on File. 2024.
- Alcon Research LLC. Data on File. 2022.
- Alcon Data on File, 2020.
- Stanojcic N, O’Brart D, Hull C, et al. Visual and refractive
outcomes and glistenings occurrence after implantation of 2
hydrophobic acrylic aspheric monofocal IOLs. J Cataract Refract
Surg. 2020;46(7):986-994.
- Clareon® Aspheric Hydrophobic Acrylic IOL – Directions for
Use.
- Clareon® PanOptix® Trifocal UV Absorbing IOL – Directions for
Use.
- Clareon® Monarch® IV IOL Delivery System – Proposed
Instructions for Use.
- National Institute for Health and Care Excellence, Cataracts in
Adults: Management. Available at:
https://pubmed.ncbi.nlm.nih.gov/29106797/. Accessed: June
2022.
- Centers for Disease Control and Prevention, Vision Health
Initiative. Available at:
https://www.cdc.gov/vision-health/about-eye-disorders/. Accessed:
February 14, 2025.
- Cataract Surgery Recovery: 8 Tips to Minimize Recovery Time.
Allaboutvision.com. Published 2019. Available at:
https://www.allaboutvision.com/treatments-and-surgery/vision-surgery/cataract/cataract-surgery-recovery/.
Accessed March 15, 2025.
For indications, contraindications and warnings please refer to
the relevant product's instructions for use.
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Media Relations Steven Smith
+ 41 589 112 111 (Geneva) + 1 817 551 8057 (Fort Worth)
globalmedia.relations@alcon.com
Investor Relations Daniel Cravens, Allen
Trang + 41 589 112 110 (Geneva) + 1 817 615 2789 (Fort Worth)
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