Alcon's Clareon Monofocal IOL Receives EUMDR Certification Through TÜV SÜD
Alcon's Clareon Monofocal intraocular lens has received EUMDR certification from TÜV SÜD. The certification validates the lens's performance in providing clear distance and intermediate vision for cataract patients.
Why it matters
This regulatory milestone reinforces the clinical efficacy of a widely used medical device, impacting global standards for cataract surgery outcomes.
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
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