Medical Device Daily

It has been a long time coming, but Advanced Medical Optics (AMO; Santa Ana, California) has finally received FDA approval of its Tecnis Multifocal intraocular lens (IOL) for cataract patients. According to AMO, the Tecnis Multifocal IOL's design gives patients "superior" near vision and reading speed compared to other presbyopia-correcting IOLs, as well as "exceptionally" high spectal independence, with nearly nine out of 10 patients reporting that they never wear glasses after surgery. The company said it would begin to ship the new IOLs to U.S. surgeons early this year.

AMO originally planned to launch the lens in the first half of 2008 but in early 2007 the company reported that the FDA had recommended it enroll additional subjects in the clinical trial for the device, which delayed its U.S. launch (Medical Device Daily, Jan. 8, 2007).

According to AMO, this IOL is the first pupil-independent, non-apodized fully diffractive aspheric lens designed to correct the two highest order aberrations – spherical and chromatic – to give patients back their youthful vision.

Speaking from the Hawaiian Eye Meeting in Maui, Giulia Newton, head of global marketing for AMO's cataract business, told Medical Device Daily that the FDA approval of the Tecnis Multifocal IOL is important for the company because currently the U.S. is the most significant market for presbyopia-correcting IOLs. Approval of the device also is important, she said, because it gives cataract patients the choice of not only having their cataract removed but also to have high-quality vision for near, far and intermediate distances, day or night.

Newton said the Tecnis Multifocal IOL allows surgeons to customize presbyopia-correcting surgery to the patient's lifestyle. Some patients, for example, do a lot of activities that require very sharp near vision such as needlepoint or reading of fine print, while others spend most of their time on the golf course and are looking for good contrast sensitivity and good distance vision.

Benefits of the Tecnis Multifocal IOL that set it apart from competing devices, Newton said, include allowing patients to see at all distances and under all light conditions. She said the new lens allows transmission of healthy blue lights, unlike the competing device, the Alcon (Fort Worth, Texas) ReSTOR, which Newton says blocks blue light.

In December, Alcon reported FDA approval of its +3.0 diopter add power AcrySof IQ ReSTOR IOL. This lens, which was introduced in many markets outside the U.S. earlier in 2008, is now approved in the U.S. for cataract surgery patients with presbyopia. The company called the lens another technology advancement for the AcrySof IQ ReSTOR platform, which was introduced in 2005.

The Tecnis Multifocal IOL is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. The IOLs are intended to be placed in the capsular bag, the company noted.

"The introduction of the Tecnis Multifocal IOL in the U.S. rounds out AMO's portfolio of market-leading, refractive technologies," said Jim Mazzo, CEO/chairman of AMO. "Following years of success in Europe, U.S. surgeons will soon be able to pass the benefits of this technology on to their patients."

"The Tecnis Multifocal IOL delivers a predictable and consistent full range of vision," said Ralph Chu, MD, founder and director of the Chu Vision Institute (Bloomington, Minnesota). "The U.S. clinical study shows that more than 94% of patients function comfortably without glasses for all distances, including intermediate. More importantly, my own patients are highly satisfied with the results."

"The full diffractive surface of the Tecnis Multifocal IOL provides high-quality vision largely independent of pupil size and reduces chromatic aberration for better image quality," said Manfred Tetz, MD, a professor of ophthalmology and director of Eye-Center-Spreebogen (Berlin, Germany). "I have been implanting the Tecnis Multifocal IOL since 2003 because of the high-quality visual results that I can provide for my patients, who report being extremely satisfied with their vision."