Alcon Clareon Monofocal IOL Receives EU MDR Certification
On September 1 2026, Alcon announced that TÜV SÜD has certified its Clareon® Monofocal intraocular lens (IOL) for compliance with the European Union Medical Device Regulation (MDR). The certification is underpinned by clinical evidence from more than thirty peer‑reviewed publications demonstrating the lens’s ability to provide sharp distance vision together with functional intermediate visual acuity.
Alcon is updating the Clareon Monofocal Instructions for Use (IFU) to incorporate an extended claim for depth of focus for intermediate tasks, as outlined in the device’s IFU. In a statement, Amar Vyas, Country Head India at Alcon, emphasized that choosing the right IOL aligns with patients’ lifestyle and surgical objectives, noting that Clareon Monofocal delivers “exceptional optical clarity and consistent performance” for both distance and enhanced intermediate outcomes.
The Clareon Monofocal IOL meets the European Society of Cataract & Refractive Surgeons (ESCRS) classification criteria for the enhanced‑monofocal category. Initially launched in 2018, the Clareon family has now exceeded 150 million implants globally. The monofocal version is supported by thirty peer‑reviewed studies that confirm its clarity, precision, and long‑term stability, with glistening‑free performance documented over three‑ and nine‑year follow‑up periods.
Constructed from a pristine hydrophobic acrylic biomaterial, Clareon exhibits some of the lowest levels of haze and glistenings compared with leading competitor IOLs, as shown in in‑vitro examinations (references 7‑9). The lens incorporates proprietary edge design to reduce glare and posterior capsular opacification, and its STABLEFORCE® haptics deliver exceptional axial and rotational stability, validated in multiple studies (references 12‑14).
Clareon Monofocal is available in both aspheric and toric configurations, the latter addressing pre‑existing corneal astigmatism. The product portfolio extends to more than 140 countries and includes additional lenses such as the Clareon PanOptix trifocal (providing 91.6 % complete spectacle independence across distance, intermediate and near) and the Clareon Vivity extended‑vision IOL (offering improved intermediate and functional near vision while maintaining distance acuity).
All Clareon IOLs are intended for placement in the capsular bag following cataract surgery. Surgeons are advised to conduct careful pre‑operative evaluation and to discuss the risk/benefit profile with patients, providing the Patient Information Brochure that outlines potential risks and benefits. The devices comply with current medical‑device legislation, and detailed Directions for Use contain full listings of indications, warnings, and precautions.
Alcon, a global leader in eye care with a heritage spanning over 75 years, serves more than 260 million people in over 140 countries each year, employing over 24,000 associates. The company’s medical‑device portfolio addresses cataracts, glaucoma, retinal diseases, and refractive errors. The Clareon Monofocal certification reinforces Alcon’s commitment to delivering innovative, high‑quality eye‑care solutions.
Reference details, study identifiers, and the last update date (14‑10‑2025) are provided in the original release.