Advanced Medical Optics, Inc. (AMO), the global leader in advanced refractive technologies for eye care professionals and patients, today announced U.S. Food and Drug Administration (FDA) approval of the TECNIS® Multifocal intraocular lens (IOL) for cataract patients.
The TECNIS® Multifocal IOL’s unique design gives patients superior near vision and reading speed compared to other presbyopia-correcting IOLs, as well as exceptionally high spectacle independence, with nearly 9 out of 10 patients reporting that they never wear glasses after surgery.
Other features/benefits include:
* high-quality vision for near, far and intermediate distances, day or night;
* first and only 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;
* 95 percent patient satisfaction – the highest of any presbyopia-correcting IOL.
“The TECNIS® Multifocal IOL delivers a predictable and consistent full range of vision,” said Ralph Chu, M.D., founder and director of the Chu Vision Institute in Bloomington, Minn. “The U.S. clinical study shows that more than 94 percent 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, M.D., 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.”
“The introduction of the TECNIS® Multifocal IOL in the U.S. rounds out AMO’s portfolio of market-leading, refractive technologies,” said AMO Chairman and CEO Jim Mazzo. “Following years of success in Europe, U.S. surgeons will soon be able to pass the benefits of this technology on to their patients.”
TECNIS® Multifocal IOLs are 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.
AMO plans to ship TECNIS® Multifocal IOLs to U.S. surgeons in early 2009.
About Advanced Medical Optics (AMO)
AMO is focused on providing the full range of advanced refractive technologies and support to help eye care professionals deliver optimal vision and lifestyle experiences to patients of all ages. Products in the cataract line include monofocal intraocular lenses (IOLs), phacoemulsification systems, viscoelastics, and related products used in ocular surgery. AMO owns or has the rights to such product brands as Tecnis®, Clariflex® and Sensar® IOLs; Sovereign®, Sovereign® Compact and WhiteStar Signature™ phacoemulsification systems with WhiteStar® technology; Healon® viscoelastics and the Baerveldt® glaucoma shunt. Products in the refractive line include wavefront diagnostic devices, femtosecond lasers and associated patient interface devices; excimer laser vision correction systems and treatment cards, and refractive implants. AMO brands in the refractive business include iDesign™, iFS™, Star S4 IR®, WaveScan Wavefront®, Advanced CustomVue™, IntraLase®, IntraLasik® and ReZoom®, Tecnis® Multifocal and Verisyse® IOLs. Products in the eye care line include disinfecting solutions, enzymatic cleaners, lens rewetting drops and artificial tears. Among the eye care product brands the company possesses are COMPLETE®, COMPLETE® Blink-N-Clean®, Consept®F, Consept® 1 Step, Oxysept® 1 Step, UltraCare®, Ultrazyme®, Total Care™ and blink® branded products. AMO is based in Santa Ana, California, and employs approximately 3,700 worldwide. The company has operations in 27 countries and markets products in approximately 60 countries.
Contact:
Investors:
Advanced Medical Optics, Inc.
Sheree Aronson, Corporate Vice President,
Investor Relations and Corporate Communications
714-247-8290
sheree.aronson@amo-inc.com
or
Media:
Global Corporate Communications
Steve Chesterman, Manager,
714-247-8711
steve.chesterman@amo-inc.com
via yahoo
The TECNIS® Multifocal IOL’s unique design gives patients superior near vision and reading speed compared to other presbyopia-correcting IOLs, as well as exceptionally high spectacle independence, with nearly 9 out of 10 patients reporting that they never wear glasses after surgery.
Other features/benefits include:
* high-quality vision for near, far and intermediate distances, day or night;
* first and only 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;
* 95 percent patient satisfaction – the highest of any presbyopia-correcting IOL.
“The TECNIS® Multifocal IOL delivers a predictable and consistent full range of vision,” said Ralph Chu, M.D., founder and director of the Chu Vision Institute in Bloomington, Minn. “The U.S. clinical study shows that more than 94 percent 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, M.D., 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.”
“The introduction of the TECNIS® Multifocal IOL in the U.S. rounds out AMO’s portfolio of market-leading, refractive technologies,” said AMO Chairman and CEO Jim Mazzo. “Following years of success in Europe, U.S. surgeons will soon be able to pass the benefits of this technology on to their patients.”
TECNIS® Multifocal IOLs are 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.
AMO plans to ship TECNIS® Multifocal IOLs to U.S. surgeons in early 2009.
About Advanced Medical Optics (AMO)
AMO is focused on providing the full range of advanced refractive technologies and support to help eye care professionals deliver optimal vision and lifestyle experiences to patients of all ages. Products in the cataract line include monofocal intraocular lenses (IOLs), phacoemulsification systems, viscoelastics, and related products used in ocular surgery. AMO owns or has the rights to such product brands as Tecnis®, Clariflex® and Sensar® IOLs; Sovereign®, Sovereign® Compact and WhiteStar Signature™ phacoemulsification systems with WhiteStar® technology; Healon® viscoelastics and the Baerveldt® glaucoma shunt. Products in the refractive line include wavefront diagnostic devices, femtosecond lasers and associated patient interface devices; excimer laser vision correction systems and treatment cards, and refractive implants. AMO brands in the refractive business include iDesign™, iFS™, Star S4 IR®, WaveScan Wavefront®, Advanced CustomVue™, IntraLase®, IntraLasik® and ReZoom®, Tecnis® Multifocal and Verisyse® IOLs. Products in the eye care line include disinfecting solutions, enzymatic cleaners, lens rewetting drops and artificial tears. Among the eye care product brands the company possesses are COMPLETE®, COMPLETE® Blink-N-Clean®, Consept®F, Consept® 1 Step, Oxysept® 1 Step, UltraCare®, Ultrazyme®, Total Care™ and blink® branded products. AMO is based in Santa Ana, California, and employs approximately 3,700 worldwide. The company has operations in 27 countries and markets products in approximately 60 countries.
Contact:
Investors:
Advanced Medical Optics, Inc.
Sheree Aronson, Corporate Vice President,
Investor Relations and Corporate Communications
714-247-8290
sheree.aronson@amo-inc.com
or
Media:
Global Corporate Communications
Steve Chesterman, Manager,
714-247-8711
steve.chesterman@amo-inc.com
via yahoo
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