Lenstec Inc. has announced that it has completed enrollment of the FDA trial for the SBL-3 IOL.
The Lenstec SBL - 3 IOL (Segmented Bi Focal Lens) is a non-concentric asymmetric multifocal refractive IOL. It provides patients with superior near, intermediate and distance vision. It also improves contrast sensitivity, and minimizes the halos and glare, (dsyphotopsias) commonly associated with other traditional concentric traditional multifocal- presbyopia correcting IOLs.
Utilizing segmented bi-aspheric optic technology, the SBL-3 has two refracting surfaces to capture light differently to the retina, for near and distance vision.
Lenstec’s patented four - point fixation shape design, and 0.25 diopter power increments enable the best Effective Lens Positioning and Visual Outcomes possible.
Upon successful completions of these trials and final FDA approval, the SBL-3 would be the first Segmented Non-Concentric Bi – Focal IOL in the U.S. market.
Lenstec is a leading designer and manufacturer of intraocular Lenses (IOLs) to treat patients with a range of vision disorders. Founded in 1993, the company is dedicated to advancing possibilities for ophthalmic professionals and their patients worldwide.
Neel R. Desai, MD, explains how the Softec HD IOL (Lenstec) benefits his practice. He describes the outcome-based conversations he has with patients about this lens and shares specific pearls for implanting this lens.
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Lenstec has stated that it has won its UK patent suit against Oculentis for bifocal IOLs. Oculentis has withdrawn legal proceedings against Lenstec in the UK High Court and made a payment towards Lenstec’s legal costs, according to a Lenstec news release.
Lenstec has agreed not to pursue Oculentis for any additional costs in what Lenstec said was always considered to be a "frivolous lawsuit and without merit." Lenstec’s SBL-3 and SBL-2 IOLs use a patented design which does not infringe on any of Oculentis’ intellectual property.
In commenting on the resolution of the legal dispute, Lenstec stated that, “The cessation of the legal proceedings and acknowledgement by Oculentis that Lenstec did not infringe on their patent is very timely. On the one hand, Lenstec is close to completing enrollment in its US clinical trial for the SBL-3 lens, so it is commercially advantageous to us. Secondly, with the growing popularity of the Extended Depth of Focus lens category, it is a great time for us to reconnect with surgeons to reiterate that all of the trifocal and other multifocal lenses remain based on a concentric ring platform, and these are renowned for high levels of dysphotopsias (halos and glare). The bifocal platform is significantly less susceptible to dysphotopsias, leading to happier patients and reliable levels of near and intermediate vision. We look forward to redoubling our efforts in the multifocal category.”
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ST. PETERSBURG, Florida, August 18, 2015—Lenstec, Inc.—an established medical device manufacturer of
technologically advanced implantable lenses for treating vision disorders—today announced the start of an
FDA trial in support of gaining FDA clearance for its Segmented Bi-focal lens (SBL-3).
Initial Experience With a New Refractive Rotationally Asymmetric Multifocal Intraocular Lens - Journal of Refractive Surgery
Recently published scientific journal article touts excellent vision outcomes with Lenstec’s SBL-3 IOL