TECNIS(R) CL Lens Designated as New Technology Intraocular Lens (NTIOL)
by U.S. Centers for Medicare and Medicaid Services (CMS)
LONDON, Sept. 9 /PRNewswire-FirstCall/ -- Advanced Medical Optics, Inc.
(AMO) (NYSE: EYE), a global ophthalmic surgical and eye care products company,
announced today from the XXIV Congress of the European Society of Cataract and
Refractive Surgeons (ESCRS) the launch of the TECNIS® CL intraocular lens
(IOL). The TECNIS(R) CL IOL is the latest advance to the TECNIS® silicone
Design enhancements of the new TECNIS(R) CL IOL include:
- Blue modified C PMMA haptics for better visibility and easier
implantation of the lens
- Frosted OptiEdge(TM) design for reduced edge glare and reduced posterior
The TECNIS® CL IOL can be implanted with the UNFOLDER(TM) Silver Series
Implantation Systems and the Silver Advanced Cartridge through a 2.8mm
incision. It permanently replaces both the Z9000 and Z9001 TECNIS® silicone
"The TECNIS® CL IOL provides the same FDA-approved claims and excellent
outcomes as the original TECNIS® lens but with a more user-friendly design,"
said AMO Corporate Vice President and Chief Marketing Officer Russ Trenary.
"We expect the TECNIS® CL lens to speed surgeon migration from
older-generation silicone lenses to the superior TECNIS® optical design.
The launch of the TECNIS® CL lens is an excellent example of how we're
continuing to refine our IOL offerings through disciplined product lifecycle
The U.S. Centers for Medicare and Medicaid Services (CMS) extended New
Technology Intraocular Lens (NTIOL) status to the TECNIS® CL lens in August.
The TECNIS® and TECNIS® CL lenses are the first and only FDA-approved IOLs
with claims for reduced spherical aberration, improved functional vision and
improved night driving simulator performance.
NTIOL designation provides for additional Medicare reimbursement of
$50 per lens for ambulatory surgical centers, which perform more than half of
all cataract surgeries in the United States. An NTIOL is defined as an IOL
that CMS determines has been approved by the FDA with labeling and advertising
claims of specific clinical advantages and superiority over existing IOLs with
regard to reduced risk of intraoperative or post-operative complication or
trauma, accelerated postoperative recovery, reduced induced astigmatism,
improved postoperative visual acuity, more stable postoperative vision, or
other comparable clinical advantages.
The TECNIS® CL IOL is available now in Europe and AMO plans to begin
shipping the lens next month in the United States, Canada and Asia Pacific,
and to Japan by mid-2007. For more information, visit: www.TECNISIOL.com.
About Advanced Medical Optics (AMO)
AMO is a global medical device leader focused on the discovery and
delivery of innovative vision technologies that optimize the quality of life
for people of all ages. Products in the cataract/implant line include
intraocular lenses, phacoemulsification systems, viscoelastics, and related
products used in cataract and refractive lenticular surgery. Products in the
laser vision correction line include laser systems, wavefront diagnostic
systems, microkeratomes and related products used in corneal refractive
surgery. AMO owns or has the rights to such ophthalmic surgical product
brands as ReZoom(TM), Clariflex®, Sensar®, CeeOn®, Tecnis® and
Verisyse(TM) intraocular lenses, STAR S4 IR(TM) laser vision correction
system, WaveScan Wavefront® System, CustomVue(TM) procedure, Sovereign®
and Sovereign® Compact(TM) phacoemulsification systems with WhiteStar®
technology, Amadeus(TM) and Amadeus(TM) II microkeratomes, Healon®
viscoelastics, and the Baerveldt® glaucoma shunt. Products in the contact
lens care line include disinfecting solutions, enzymatic cleaners and lens
rewetting drops. Among the eye care product brands the company possesses are
COMPLETE® Moisture PLUS(TM), COMPLETE® Blink-N-Clean®, Consept®F,
Consept® 1 Step, Oxysept® 1 Step, UltraCare®, Ultrazyme®, Total
Care(TM) and blink(TM) branded products. Amadeus is a licensed product of,
and a trademark of, SIS, Ltd. AMO is based in Santa Ana, California, and
employs approximately 3,600 worldwide. The company has operations in
24 countries and markets products in approximately 60 countries. For more
information, visit the company's Web site at www.amo-inc.com.
This press release contains forward-looking statements about AMO,
including Mr. Trenary's statements and those relating to the launch and
features of the product. All forward-looking statements in this press release
are based on estimates and assumptions and represent AMO's judgment only as of
the date of this press release. Actual results may differ from current
expectations based on a number of factors including but not limited to market
developments, expanded clinical experience, unexpected delays in
manufacturing, and unexpected regulatory or quality issues. Therefore, the
reader is cautioned not to rely on these forward-looking statements. AMO
disclaims any intent or obligation to update these forward-looking statements.
Additional information concerning these and other risk factors may be
found in previous financial press releases issued by AMO and AMO's public
periodic filings with the Securities and Exchange Commission, including the
discussion under the heading "Risk Factors" in AMO's 200 Form 10-K filed in
March 2006. Copies of press releases and additional information about AMO are
available at www.amo-inc.com, or by contacting AMO's Investor Relations
Department by calling 714-247-8348.
SOURCE Advanced Medical Optics, Inc.