Advanced Medical Optics, Inc. (AMO) recently announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of Healon D(R) 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.

According to AMO, Healon D(R) 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(R) OVD coats the cornea and remains in place throughout the entire surgical process. Its lower viscosity provides ideal lubrication of IOL insertion systems. AMO also says that Healon GV(R) viscoelastic has the highest molecular weight of any OVD on the market and its high viscosity allows for increased anterior chamber expansion and maintenance as well as providing exceptional control for the surgeon during ophthalmic surgery.

"Whether I will be using it exclusively, or in combination with other Healon(R) OVDs, Healon D(R) 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(R) 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(R) OVD, the company says, allows AMO to introduce for the first time two new dual-pack ophthalmic viscosurgical systems featuring Healon D(R) and Healon GV(R) OVDs as well as Healon D(R) and standard Healon(R) OVDs in combination packs. AMO plans to ship Healon D(R) OVD and the new dual-packs in the fourth quarter.

Adapted from a press release from Advanced Medical Optics.

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