Lenstec has announced its has submitted a premarket approval (PMA) application to the FDA for the SBL-3 IOL.
The Lenstec SBL-3 (segmented bifocal lens) is an asymmetric multifocal refractive IOL utilizing a 3-diopter add with a transition zone connecting the distance and near segments. It provides patients with near, intermediate, and distance vision. In comparison to other available multifocal IOL’s, it shows a reduced occurrence of halos and glare and improved contrast sensitivity, according to a company news release.
Utilizing segmented bi-aspheric optic technology, the SBL-3 has two refracting surfaces to capture light on different parts of the retina for near, intermediate, and distance vision. Lenstec’s patented four-point fixation shape design, and 0.25 D power increments enables more effective lens positioning and visual outcomes.
“This is an exciting milestone for Lenstec and brings us closer to completing regulatory approval in the US,” Lenstec’s VP Sales and Marketing Gary Lattanzio said in the news release.
If FDA approved, the SBL-3 would be the first segmented bifocal IOL in the U.S. market. The SBL 3 is available in markets outside the US.