The FDA has approved a hydrophobic acrylic IOL (enVista, Bausch + Lomb [B + L]), and once the FDA clears its its supporting insertion system, the lens will be fully released commercially in the United States.
Aliso Viejo, CA-The FDA has approved a hydrophobic acrylic IOL (enVista, Bausch + Lomb [B + L]), and once the FDA clears its supporting insertion system, the lens will be fully released commercially in the United States.
“Based on my experience, the new . . . 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,” said Louis D. “Skip” Nichamin, MD, medical director of the Laurel Eye Clinic and the Laurel Laser and Surgery Center, Brookville, PA. He was one of the principal investigators in the FDA investigational device exemption trial of the lens.
According to the manufacturer, it is the first and only FDA-approved IOL in the United States with labeling that states: “No glistenings of any grade were reported for any subject at any visit in the clinical study.” Literature reports indicate that glistenings may not only present an aesthetic issue for surgeons after surgery; they also can affect visual function, including visual acuity and contrast sensitivity in patients because a portion of light coming into the eye is scattered.
“We’ve listened to our customers tell us how frustrating glistenings can be when conducting post-surgical examinations of their patients,” said Cal Roberts, MD, executive vice president and chief medical officer, B + L. “We are proud to offer them an attractive, viable, and technologically advanced option to address this concern.”
The IOL is a “key milestone” for the company, marking its entry into the hydrophobic acrylic market, according to John Barr, executive vice president and global president, B + L Surgical. “We’re happy to be the only company with the distinction of offering an IOL proven to be glistening-free,” he added.
The lens offers aspheric, aberration-free advanced optics technology, according to the company, and is designed to minimize posterior capsular opacification, which causes vision to become clouded after surgery.
The IOL received CE mark approval in the European Union in September 2011 and is awaiting other approvals worldwide.
For more articles in this issue of Ophthalmology Times eReport, click here.