Oct 7 2008
Advanced Medical Optics, Inc., the global leader in advanced refractive technologies for eye care professionals and patients, today announced the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of Healon D® viscoelastic, a clear dispersive ophthalmic viscosurgical device (OVD) for use as a surgical aid in cataract extraction, intraocular lens (IOL) implantation, corneal transplant, and glaucoma filtration surgery.
Healon D® OVD’s formula provides exceptional clarity in the surgical field and a high degree of protection of corneal endothelial cells. Due to its low molecular weight, Healon D® OVD coats the cornea and remains in place throughout the entire surgical process. Its lower viscosity provides ideal lubrication of IOL insertion systems. Like all members of the Healon® family, Healon D® OVD is latex free, which means a safer environment for patients and physicians.
“Whether I will be using it exclusively, or in combination with other Healon® OVDs, Healon D® viscoelastic will help me deliver optimal clinical outcomes for my patients,” said Dr. Roger Steinert, director, cornea, refractive and cataract surgery, and vice chair, clinical ophthalmology at the University of California, Irvine. “The Healon® family of OVDs provides me with the complete range of viscosurgical tools I need during every step of cataract surgery.”
The FDA’s approval of Healon D® OVD allows AMO to introduce for the first time, two new dual-pack ophthalmic viscosurgical systems (OVS) featuring Healon D® and Healon GV® OVDs as well as Healon D® and standard Healon® OVDs in convenient combination packs.
Healon GV® viscoelastic is a cohesive OVD that provides exceptional control for the surgeon during ophthalmic surgery. It has the highest molecular weight of any OVD on the market and its high viscosity allows for increased anterior chamber expansion and maintenance.
AMO plans to ship Healon D® OVD and the new dual-packs in the fourth quarter.