Bausch + Lomb has received U.S. Food and Drug Administration approval for enVista, a hydrophobic acrylic IOL, according to a press release.
The labeling of the IOL notes, “No glistenings of any grade were reported for any subject at any visit in the clinical study.”
Glistenings can affect visual acuity and contrast sensitivity because of the fluid-filled microvacuoles that can form within the IOL. They are common in some hydrophobic acrylic IOLs.
“The new enVista hydrophobic acrylic IOL is an exciting addition to our IOL choices, as it has been clinically proven to be free of glistenings, a common issue observed in some other hydrophobic IOLs,” Louis D. “Skip” Nichamin, MD, one of the principle investigators in the FDA investigational device exemption trial for enVista and OSN Cataract Surgery Board Member, said in the release.
EnVista has a combination of aspheric, aberration-free Advanced Optics technology, and it is designed to minimize posterior capsular opacification.
The lens received CE mark approval in the European Union in September 2011 and is pending approvals worldwide. Commercial release of the IOL in the U.S. is planned upon FDA clearance of its insertion system.