FDA approves Softec HD IOL
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ST. PETERSBURG, Fla. — The U.S. Food and Drug Administration has approved the Softec HD IOL, manufacturer Lenstec announced in a press release.
The Softec HD is part of Lenstec's precision series of IOLs, designed to offer a high level of refractive precision and predictability, according to the release.
The lens is manufactured with a tolerance of 0.125 D, three times more precise than lenses made under less strict standards. The lens is designed to minimize variability, which is the difference between a labeled prescription and the actual power of a lens after implantation, the release said.
The Softec HD is manufactured in 0.25 D increments for prescriptions of +18 D to +25 D. Other standard IOLs that are made in 0.5 D increments may deviate up to 0.25 D from a patient's prescription, the release said.
The lens is widely used in the European Union, Australia, Canada, China and other markets. More than 1 million Softec IOLs have been implanted since 2005.
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