Viscoelastic receives FDA approval

October 15, 2008

Advanced Medical Optics (AMO) announced that the FDA has granted premarket approval of a viscoelastic (Healon D), a clear dispersive ophthalmic viscosurgical device (OVD) for use as a surgical aid in cataract extraction, IOL implantation, corneal transplant, and glaucoma filtration surgery.

Santa Ana, CA-Advanced Medical Optics (AMO) announced that the FDA has granted premarket approval of a viscoelastic (Healon D), a clear dispersive ophthalmic viscosurgical device (OVD) for use as a surgical aid in cataract extraction, IOL implantation, corneal transplant, and glaucoma filtration surgery.

Due to its low molecular weight, the OVD coats the cornea and remains in place throughout the entire surgical process. The latex-free OVD has a lower viscosity, providing ideal lubrication of IOL insertion systems, according to the company.

"Whether I will be using it exclusively, or in combination with other . . . OVDs, [this] viscoelastic will help me deliver optimal clinical outcomes for my patients," said Roger Steinert, MD, director, cornea, refractive, and cataract surgery, and vice-chairman, clinical ophthalmology at the University of California, Irvine. "The . . . family of OVDs provides me with the complete range of viscosurgical tools I need during every step of cataract surgery."

The FDA approval of the OVD also allows AMO to introduce two new dual-pack ophthalmic viscosurgical systems that contain the OVD as part of convenient combination packs.

The OVD and dual packs will be available in the fourth quarter, according to a prepared statement issued by AMO.