FDA approves TECNIS(R) foldable acrylic intraocular lens
Aug 10, 2005 - 8:32:38 PM
Advanced Medical Optics, Inc. (AMO) , today announced that the U.S. Food & Drug Administration (FDA) has approved the TECNIS(R) intraocular lens (IOL) on an acrylic platform.
The TECNIS(R) foldable acrylic IOL offers surgeons and their patients the same unique benefits as the TECNIS(R) silicone IOL. AMO is the only company to market IOLs with a claim approved by the FDA for reduced spherical aberration and improved functional vision.
"FDA approval of the TECNIS(R) acrylic IOL marks an important milestone for AMO because it represents the first approved product that combines the outstanding optical technology from our 2004 acquisition of the Pfizer ophthalmic surgical business, with our existing advanced IOL materials expertise," said AMO President and CEO Jim Mazzo. "This FDA approval broadens our portfolio of acrylic IOLs, providing more options for our customers and their patients."
Visual performance degrades with age, including a loss of functional vision, which is caused by an increase in the optical aberration of the eye that may result in difficulty seeing in low light conditions. Cataract patients with reduced functional vision may be challenged driving at dusk or at night, experience trouble reading or doing work at close range, or lack confidence navigating stairs or unfamiliar settings. The TECNIS(R) lens reduces spherical aberration and improves functional vision in varying light conditions, which is likely to provide a meaningful safety benefit for older drivers and pedestrians with whom they share the road.
In a simulated night driving study, patients viewing a rural road through the TECNIS(R) lens identified a pedestrian hazard significantly sooner than through a traditional spherical IOL. The TECNIS(R) lens also provided a 45-foot advantage in detection and identification distance. At 55 MPH, this would provide an additional 0.5 seconds to perceive and react to a pedestrian hazard.
AMO plans to release the TECNIS(R) foldable acrylic IOL commercially in the U.S. and Europe in September 2005.
About the TECNIS(R) IOL
The eyes, like other parts of the body, actually fall out of balance with age. The cornea and natural crystalline lens of a young person work together to focus light onto the retina. Over time, the natural lens loses some of its ability to balance the cornea, resulting in vision that is not quite as crisp as it used to be. Typical cataract surgery restores cornea/lens balance to a level equivalent to that of a healthy older person. The TECNIS(R) lens implant restores the cornea/lens balance to a level more like that of a healthy younger person. While most IOLs are made with a spherical (rounded) surface, the TECNIS(R) lens is an aspheric wavefront-designed optic. This design was developed by collecting actual wavefront measurements from human corneas of a representative sample of the population. Then, a modified prolate intraocular lens surface was created that reduces spherical aberration and works with the cornea in a way that more closely resembles the balance of a natural lens and cornea of a young person. The result is improved functional vision for most people after cataract surgery.
TECNIS(R) foldable intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adults in whom a cataractous lens has been removed by phacoemulsification. The lenses are intended to be placed in the capsular bag. Rx Only. For a complete listing of precautions, warnings and adverse events, refer to the package insert.
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