Alcon Receives EUMDR Certification for Clareon Monofocal IOL Through TÜV SÜD

Global eye care leader Alcon has secured EUMDR certification for its Clareon Monofocal intraocular lens through TÜV SÜD. The certification is backed by clinical evidence from over 30 peer-reviewed publications and meets ESCRS criteria for the enhanced monofocal category.

BANGALORE, India — Alcon, a global eye care company, has announced that TÜV SÜD has certified the Clareon Monofocal intraocular lens (IOL) for MDR compliance.

The certification is supported by clinical evidence, including more than 30 peer-reviewed publications. These studies demonstrate the lens's ability to deliver distance vision alongside functional intermediate visual acuity. Alcon is currently updating the Clareon Monofocal Instructions For Use (IFU) to reflect the extended claim for depth of focus for intermediate tasks.

Amar Vyas, Country Head India at Alcon, stated that choosing the right IOL involves aligning with a patient's lifestyle and surgical objectives. He noted that the Clareon Monofocal IOLs provide optical clarity and performance, helping surgeons achieve distance and enhanced intermediate visual outcomes.

Additionally, the Clareon Monofocal meets the European Society of Cataract and Refractive Surgeons (ESCRS) criteria for the Society's enhanced monofocal category. Initially launched in 2018, Clareon IOLs have surpassed use in 150 million eyes globally. The Clareon Monofocal is currently available in more than 140 countries.

The Clareon portfolio includes various intraocular lenses designed for adult patients following cataract surgery, such as the Clareon Aspheric Hydrophobic Acrylic, Clareon Aspheric Toric, Clareon PanOptix Trifocal, and Clareon Vivity Extended Vision lenses. These products are intended for placement in the capsular bag following careful preoperative evaluation by surgeons.

Alcon continues to operate globally with a workforce of more than 24,000 associates, offering surgical and vision care products designed to address conditions such as cataracts, glaucoma, retinal diseases, and refractive errors across multiple markets.

"Regulatory approvals such as the EUMDR certification play a critical role in validating the clinical efficacy and safety of medical devices in competitive international markets. For established global enterprises like Alcon, meeting rigorous standards set by bodies like TÜV SÜD reinforces product reliability and strengthens market access across multiple regions. This development highlights the importance of continuous clinical backing and compliance in the specialized medical technology sector." — Dr. Shishir Gupta, Founder & CEO, StartupLanes