Alcon's Clareon Monofocal IOL Receives EUMDR Certification Through TÜV SÜD

• Recognizes Clareon Monofocal as an excellent choice for surgeons who want predictable, consistent outcomes, and for patients who value functional intermediate visual acuity without compromising distance vision¹
• Extends depth of focus for intermediate tasks as per Clareon IFU¹, and meets ESCRS classification criteria for enhanced monofocal²
• Also available in Toric for astigmatic patients³, with over 150 million Clareon IOL implants worldwide⁴

BANGALORE, India, Sept. 1, 2026 /PRNewswire/ -- Alcon, a global leader in eye care, announced that TÜV SÜD has certified the Clareon^® Monofocal intraocular lens (IOL) for MDR compliance. This certification is supported by clinical evidence, including more than 30 peer-reviewed publications demonstrating the Clareon^® Monofocal IOL's ability to deliver sharp, clear distance vision along with functional intermediate visual acuity.¹ Alcon is currently updating the Clareon Monofocal IFU to reflect the extended claim for depth of focus for intermediate tasks.

"For nearly 80 years, Alcon has advanced cataract surgery through continuous innovation," said Amar Vyas, Country Head India at Alcon. "Choosing the right IOL is about more than vision correction—it's about aligning with each patient's lifestyle and surgical objectives. Clareon Monofocal IOLs deliver exceptional optical clarity and consistent performance, enabling surgeons to achieve reliable distance—and enhanced intermediate—visual outcomes for their monofocal patients."^1,5 

Additionally, the Clareon Monofocal meets ESCRS criteria for the Society's enhanced monofocal category.² Initially launched by Alcon in 2018, Clareon IOLs have now surpassed 150 million eyes globally.⁴ Today, Clareon Monofocal is backed by proven clarity, precision, and stability, established in 30 peer-reviewed studies.⁶ Achieving ESCRS certification of Clareon monofocal as an enhanced monofocal confirms compliance with recognized standards for optical performance.²

Designed for Consistent, Predictable Performance and Outcomes that Surgeons can Trust

Clareon is a pristine hydrophobic acrylic BioMaterial with one of the lowest levels of haze and glistenings^*† compared to leading competitor IOLs, ^7-9 marking a significant advancement for surgeons and patients.  In long-term clinical studies, Clareon IOLs were reported as glistening-free over three (3) and nine (9) years.^7,9,10

Clareon Monofocal aspheric and Toric IOLs offer sharp, crisp vision with a proprietary edge designed to help reduce glare and posterior capsular opacification.¹¹ Additionally, the lens' unique and proven STABLEFORCE^® Haptics provide exceptional axial and rotational stability.^12-14

Clareon Monofocal is available in more than 140 countries. To learn more about the Clareon portfolio, including Clareon Monofocal, visit https://www.myalcon.com/in/professional/cataract-surgery/iols/clareon-monofocal/ 

About Clareon^® IOLs and Delivery Systems

The family of Clareon intraocular lenses (IOLs) includes the Clareon Aspheric Hydrophobic Acrylic and Clareon Aspheric Toric IOLs, the Clareon PanOptix Trifocal Hydrophobic IOL, Clareon PanOptix Toric, Clareon Vivity Extended Vision Hydrophobic Posterior Chamber IOL and Clareon Vivity Toric IOLs. Each of these IOLs is indicated for visual correction of aphakia in adult patients following cataract surgery. In addition, the Clareon Toric IOLs are indicated to correct pre-existing corneal astigmatism at the time of cataract surgery. The Clareon PanOptix lens mitigates the effects of presbyopia by providing a sharp, crisp vision at distance, intermediate and near with 91.6% of patients having complete spectacle independence for a full range of vision.^15,16 The Clareon Vivity lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and functional near visual acuity while maintaining comparable distance visual acuity with a monofocal visual disturbance profile. ^{§§ ‡1,17-20} 

All of these IOLs are intended for placement in the capsular bag. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting any IOL in a patient with any of the conditions described in the Directions for Use that accompany each IOL. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon, informing them of possible risks and benefits associated with these IOLs. Reference the Directions for Use labelling for each IOL for a complete listing of indications, warnings and precautions.

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 24,000 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.

Alcon medical device(s) comply with the current legislation for the medical devices. Please refer to relevant products instructions for use for complete list of indications, contraindications and warnings.

* 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, TCNS^§ ZxBx0, TCNS^§ OB, ET^§ W-6x and enV^§ MX6x; n=30 per group; p<.001

‡ AcrySof IQ Vivity and Clareon Vivity are optically equivalent.

^§ Trademarks are the property of their respective owners.

^§§ Results from a prospective/retrospective, multicenter, non-randomized, parallel-group, controlled, assessor-masked interventional study comparing the performance of Clareon Vivity and Vivity Toric IOLs (n=75) with Clareon Monofocal and Clareon Toric IOLs (n=73), with 90–180 days of follow-up

Brand references in anonymized form are used for illustrative and informational purposes only. No direct comparison or identification of competitor brand is intended

For the use/reference only of registered medical practitioners or a hospital or a laboratory

Brand Name: Clareon™ IOL &  Clareon™ Toric IOL  

Imported & Marketed by: Alcon Laboratories (India) Pvt. Ltd., 11th Floor, RMZ Azure, Bellary Road, Hebbal, Bengaluru – 560092

Please refer to the relevant product DFU for detailed list of indications, warnings, precautions for use, contraindications, etc.. Additional information is available on request.    Date last updated: 14-10-2025

References

1.  Berdahl JP, Grosinger L, Reed O. Visual Performance of a Novel Wavefront Shaping Extended Depth-of-Focus Intraocular Lens on a New Hydrophobic Acrylic Platform. J Cataract Refract Surg. 2025 Jul 21
2.  Ribeiro F, Dick HB, Kohnen T, Findl O, Nuijts R, Cochener B, Fernández J. Evidence-based functional classification of simultaneous vision intraocular lenses: seeking a global consensus by the ESCRS Functional Vision Working Group. J Cataract Refract Surg. 2024 Aug 1;50(8):794-798.
3.  Clareon^® Toric Directions for Use.
4.   Alcon data on file, REF-24499, 2025
5.  Micheletti JM, Duncan NB, Hall B. Head-to-Head Comparison of Intermediate Vision of Two Monofocal Intraocular Lenses. Clin Ophthalmol. 2023 Dec 21;17:3983-3990
6.  Clareon Monofocal 30+ peer-reviewed studies evidence, REF-27708, 2025. https://pubmed.ncbi.nlm.nih.gov/?term=clareon+monofocal
7.  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.
8.  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.
9.  Werner L, Thatthamla I, Ong M, et al. Evaluation of clarity characteristics in a new hydrophobic acrylic IOL. J Cataract Refract Surg. 2019;45:1490-1497.
10.  Maxwell A, Suryakumar R. Long-term effectiveness and safety of a three-piece acrylic hydrophobic intraocular lens modified with hydroxyethyl-methacrylate: an open-label, 3-year follow-up study. Clin Ophthalmol. 2018;12:2031-2037.
11.  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.
12.  Schartmüller D, Lisy M, Mahnert N, Schranz M, Danzinger V, Schwarzenbacher L, Pieh S, Abela-Formanek C, Leydolt C, Menapace R. Rotational stability and refractive outcomes of a new hydrophobic acrylic toric intraocular lens. Eye Vis (Lond). 2024 Jul 2;11(1):25.
13.  Walters TR, Lehmann R, Moyes A, French JW, Sreenivasan V, Modi SS. Rotational Stability of the Clareon Monofocal Aspheric Hydrophobic Acrylic Intraocular Lens 6 Months After Implantation. Clin Ophthalmol. 2022 Feb 15;16:401-409.
14.  Lane S, Collins S, Das KK, Maass S, Thatthamla I, Schatz H, Van Noy S, Jain R. Evaluation of intraocular lens mechanical stability. J Cataract Refract Surg. 2019 Apr;45(4):501-506.
15.  Alcon Vision LLC. Clareon® PanOptix® Trifocal Hydrophobic Acrylic IOL. Product Information. 2021.
16.  Zhu D, Ren S, Mills K, Hull J, Dhariwal M. Rate of complete spectacle independence with a trifocal intraocular lens: A systematic literature review and meta-analysis. Ophthalmology and Therapy. 2023;12(2):1157-1171. doi:10.1007/s40123-023-00657-5
17.  Clareon Vivity Directions for Use.
18.  Kohnen T,  et al. Clin Ophthalmol. 2023;17:2449–2457.
19.  Bala C, et al. J Cataract Refract Surg. 2022;48(2):136–143. 5.McCabe C, et al. J Cataract Refract Surg. 2022;48(11):1297–1304.
20.  Howes F, et al. J Refract Surg. 2025;41(2):e131.

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