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The FDA has cleared a new C-loop, single-piece hydrophilic acrylic IOL (Softec ONE, Lenstec) for the treatment of patients with cataracts.
St. Petersburg, FL-The FDA has cleared a new C-loop, single-piece hydrophilic acrylic IOL (Softec ONE, Lenstec) for the treatment of patients with cataracts, according to the manufacturer.
The new lens’ uniplanar design and equal biconvex spherical optic are designed to ease implantation by allowing surgeons to insert the lens without regard to whether it is “right-side up.” The design is based on that of another lens (Softec HD, Lenstec) cleared by the FDA earlier this year.
“Receiving our second FDA approval within 90 days affirms the quality of our manufacturing and our excellence in regulatory compliance,” said John Clough, Lenstec president and chief executive officer.
The newly approved IOL has been implanted globally for more than 10 years, according to the company.