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Lenstec Receives FDA Approval For Softec HD Lens

Lenstec, a manufacturer of technologically-advanced implantable lenses, has received FDA approval for Softec HD Intraocular Lens (IOL) Implant for treating patients with cataracts.

Lenstec said that with the approval, cataract patients in the US can benefit from Softec HD’s advanced technology, which is expected to be displayed at the American Society of Cataract and Refractive Surgeons (ASCRS) Symposium and Congress in Boston.

The newly approved Softec HD is part of Lenstec’s ‘Precision Series’ of implantable IOLs that enable ophthalmologists to achieve predictability and precision in vision surgery.

Based on Lenstec’s 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.

Lenstec claimed that 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.

Jim Simms, vice president of Lenstec, said: “Lens variability is one of the leading causes of refractive error for patients who undergo cataract surgery. Our ‘Precision Series’ technology reduces such variability and enables surgeons to better target each patient’s prescription.

“The only way to reduce such variability is to manufacture a more precise lens. While this requires more effort, we have been able to make the process scalable in a way that larger implantable lens manufacturers with legacy systems simply can’t match.”