Announcement

Alcon announced that TÜV SÜD has issued an EU MDR (Medical Device Regulation) certification for its Clareon® Monofocal intraocular lens (IOL). The certification is based on clinical evidence, including more than 30 peer‑reviewed publications demonstrating sharp distance vision and functional intermediate visual acuity.

Product Highlights

  • The Clareon Monofocal IOL is described as an excellent choice for surgeons seeking predictable, consistent outcomes and for patients valuing functional intermediate acuity without compromising distance vision.
  • It extends depth of focus for intermediate tasks as per the updated Instructions for Use (IFU) and meets the European Society of Cataract & Refractive Surgeons (ESCRS) classification criteria for an enhanced monofocal lens.
  • A toric version is available for patients with pre‑existing corneal astigmatism.
  • The lens is made from a pristine hydrophobic acrylic biomaterial with the lowest reported levels of haze and glistenings compared with leading competitor IOLs, and long‑term studies show it remains glistening‑free for up to nine years.
  • The proprietary STABLEFORCE® haptics provide exceptional axial and rotational stability, reducing glare and posterior capsular opacification.

Market Reach

  • Since its launch in 2018, more than 150 million Clareon IOLs have been implanted worldwide.
  • The product portfolio is marketed in over 140 countries.
  • Alcon’s global eye‑care business serves more than 260 million patients annually across 140 countries, employing over 24,000 associates.

Regulatory and Label Updates

  • Alcon is revising the Clareon Monofocal IFU to incorporate the extended depth‑of‑focus claim for intermediate tasks.
  • The device complies with current EU medical‑device legislation; users must refer to the Directions for Use for full indications, warnings, and precautions.

Executive Comment

Amar Vyas, Country Head India for Alcon, stated that “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.”

References

The release cites peer‑reviewed studies (e.g., Berdahl et al., 2025; Ribeiro et al., 2024) and Alcon internal data (REF‑24499, 2025) supporting the claims. Additional clinical evidence includes 30+ publications, long‑term glistening‑free results at three and nine years, and stability data from multiple studies (e.g., Schartmüller et al., 2024; Walters et al., 2022).