Zeiss announces FDA approval of monofocal IOL

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Carl Zeiss Meditec AG announced FDA approval of its CT Lucia 621P monofocal IOL, an aspheric, monofocal, single-piece C-loop IOL.

According to the company, the IOL features the patented Zeiss Optic (ZO) Asphericity Concept, which is designed to compensate for a wide range of spherical aberrations and at the same time optimize visual outcomes in the event of potential decentration and lens misalignments.

“This is my standard, go-to monofocal lens. It's one we use routinely in our practice and even for complex cases,” Sri Ganesh, MD, Chairman and Managing Director of Nethradhama Super Speciality Eye Hospital, Bangalore, India, said in a statement. “Since it's a preloaded lens that is easy to use, it's very predictable. And the refractive stability is reliable from 15-day post-op to three months, or even one year out.”

The monofocal IOL is a key element of the Zeiss cataract workflow solution portfolio enabling surgeons to deliver optimized visual outcomes for cataract patients. Along with the Zeiss Optic (ZO) Asphericity Concept, the IOL comes in a fully preloaded injector for an intuitive, smooth, and controlled injection. Additionally, the architecture of the IOL is designed to enable easy centering while maximizing direct capsular contact, thus ensuring stability and supporting a consistent position in the bag.

“Even in a standard case where everything goes well, we may see short and/or long-term decentration because each eye is anatomically a little different. What is great about the Zeiss Optic is it combines advantageous qualities of both aspheric and spherical lenses, making the lens design less susceptible to optical decentration issues even up to a millimeter, thus helping to maintain optical quality. Zeiss has a brand built on high quality optics like this,” William Wiley, MD, medical director of the Cleveland Eye Clinic, said in a statement

“The CT LUCIA 621P Monofocal IOL is a great example of how our latest ophthalmic innovations are driving efficiency and better patient outcomes in the United States,” Euan S. Thomson, PhD, president of Ophthalmology Strategic Business Unit and Head of the Digital Business Unit for ZEISS Medical Technology, said in a statement. “We believe this monofocal IOL will promote better surgical management and help set new standards for cataract patient care.”