Lenstec out of St. Petersburg, FL won FDA regulatory approval for the company’s Softec HD intraocular lens prosthesis (IOL). The device uses an aspheric lens with no inherent spherical aberration, which should increase image quality for the patients wearing them compared with traditional IOLs.
The device already has approval in the EU, Canada, and much of the rest of the world.
Based on Lenstec’s proprietary lens manufacturing technology, the Softec HD is designed to make cataract surgery more predictable by reducing the variability inherent in any manufactured lens. When it comes to lenses used for vision correction, variability is defined as the tolerance or margin of error measured by the difference between a lens’ labeled prescription and its actual power.
The Softec HD is manufactured with a tolerance of just 0.125D (diopters), which is up to three times more precise than cataract replacement lenses manufactured under less stringent ISO standards.
In addition to reducing variability, Lenstec’s high-precision manufacturing process makes it possible to produce Softec HD lenses in 0.25D increments for prescriptions from +18D to +25D. In contrast, standard IOLs from other manufacturers are available only in 0.5D increments, which means they can be up to 0.25D out of step with a patient’s lens prescription.
Press release: Cataract Treatment Gets More Precise With FDA Approval of Softec HD™ Lens
Product page: Softec HD