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The FDA granted approval March 10 for marketing of a single-piece version of a multifocal IOL for cataract patients with and without presbyopia.
The FDA granted approval March 10 for marketing of a single-piece version of a multifocal IOL (Tecnis Multifocal, model ZMB00, Abbott Medical Optics) for cataract patients with and without presbyopia.
The newly approved multifocal one-piece IOL also has received presbyopia-correcting IOL status by the Centers for Medicare and Medicaid Services.
"The real-world outcomes are mimicking the findings of the clinical trials in terms of predictable refractive results, excellent uncorrected visual acuity at all distances, high rates of spectacle independence, and minimal problems with glare and halos," said Dr. Davis, director, Minnesota Eye Laser and Surgery Center, Minnesota Eye Consultants, Bloomington, MN, and adjunct clinical assistant professor, department of ophthalmology, University of Minnesota, Minneapolis.
There are several elements of the multifocal optic that explain its outstanding functional performance. Excellent quality of vision can be attributed to its aspheric anterior surface, which is designed to correct the population average amount of corneal spherical aberration, and to several features that reduce chromatic aberrations, including its diffractive design, high ABBE number, and high reading add (optical power +4 D).
"Some surgeons wonder why the +4 D reading add does not translate into the same close near focal point that is seen in patients with the AcrySof IQ ReSTOR +4.0 Multifocal IOL (SN6AD3, Alcon Laboratories) implanted," Dr. Davis said. "The difference may be explained in part by the fact that the diffractive rings are on the posterior surface of the Tecnis optic but on the anterior surface of the ReSTOR IOL.