Advanced Medical Optics, Inc., a global leader in ophthalmic surgical devices and eye care products, today announced the U.S. introduction of the TECNIS® 1-Piece intraocular lens (IOL).
The TECNIS® 1-Piece IOL’s innovative design and ease-of-use enhancements combine with the proven TECNIS® IOL optics to reduce spherical aberration to essentially zero, and improve night driving simulator performance. By targeting zero spherical aberration, TECNIS® lenses are designed to provide rejuvenated vision, more like that of a younger adult with no spherical aberration.
The TECNIS® 1-Piece IOL design combines two ground-breaking design advancements. The innovative ProTec™ 360-degree edge design has an uninterrupted barrier edge designed to minimize cell migration onto the posterior capsule. Unlike first generation one-piece lenses, the TECNIS® 1-Piece IOL has no interruption at the haptic-optic junction. The lens also has a frosted edge designed to minimize edge glare. The TECNIS® IOL Tri-Fix™ design provides three-point fixation for exceptional stability. Refraction stabilizes quickly after the implantation procedure.
"My expectations after 20 years for IOL performance are very high,” said Donald R. Nixon, MD FRSC C. “The TECNIS® 1-Piece IOL has surpassed these expectations, especially for visual outcomes and optic clarity. In addition, this new generation one-piece design has responded to the issues associated with existing one-piece IOLs."
Made of a hydrophobic acrylic material that blocks UV light, the TECNIS® 1-Piece IOL transmits the healthy blue light needed for improved scotopic (dim light) vision and healthy circadian rhythms. With its simple, one-piece design and reduced center thickness, it is easy to implant with bag-friendly coplanar delivery and gently unfolding haptics.
AMO received approval from the Food and Drug Administration (FDA) for the lens on October 30, 2007. The TECNIS® 1-Piece IOL received the same claims of reduced spherical aberrations and improved night driving simulator performance as the other IOLs in the TECNIS® portfolio.
The TECNIS® 1-Piece IOL has been designated as a New Technology Intraocular Lens (NTIOL) by the Centers for Medicare and Medicaid Services (CMS).
CMS recognized the TECNIS® 1-Piece IOL (Model ZCB00) as a member of the Reduced Spherical Aberration NTIOL subset and approved the lens for reimbursement status that provides for additional Medicare reimbursement of $50 per lens for ambulatory surgical centers, which perform more than half of all cataract surgeries in the U.S. AMO’s TECNIS® foldable three-piece IOL was the first lens designated as an NTIOL for reduction of spherical aberration in January 2006.
CMS can designate NTIOL status to any IOL that has been approved by the FDA with label 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® 1-Piece IOL marks the fifth NTIOL designation for the TECNIS® portfolio of lenses and clearly demonstrates the technological superiority of this platform,” said AMO Chairman and CEO Jim Mazzo. “With this latest NTIOL designation, CMS has further validated the distinct clinical advantages the TECNIS® brand of IOLs provides to surgeons and the patients they treat.”
The TECNIS® 1-Piece IOL was launched in Europe in September 2007.