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news.Advanced Medical Optics has received the FDA's premarket approval for Healon D viscoelastic, a clear, dispersive ophthalmic viscosurgical device for use as a surgical aid in cataract extraction, intraocular lens implantation, corneal transplant and glaucoma filtration surgery.
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The FDA’s approval of Healon D ophthalmic viscosurgical device (OVD) allows Advanced Medical Optics (AMO) to introduce for the first time, two new dual-pack ophthalmic viscosurgical systems featuring Healon D and Healon GV OVDs as well as Healon D and standard Healon OVDs in convenient combination packs, the company said.
According to the company, 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 intraocular lenses insertion systems, the company added.
AMO plans to ship Healon D OVD and the new dual-packs in the fourth quarter of 2008.