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FDA Approves Staar Surgical Toric Visian ICL

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Now you can have clear Vision without glasses or contacts! The Visian Toric ICL can correct Nearsightedness and Astigmatism.

  • Are nearsighted with  astigmatism from -3.0 D to ≤ -15.0 D (spherical equivalent) with astigmatism of 1.0 D to 4.0 D (Eyeglass measurements)
  • Are nearsighted with  astigmatism with spherical equivalent ranging from greater than -15.0 D to -20.0 D (spherical equivalent) with astigmatism of 1.0 D to 4.0 D (Eyeglass measurements)
  • Have an anterior chamber depth (ACD) of 3.00 mm or greater, from the  back of the cornea to the front  surface of the natural lens
  • You must have a stable refractive history (within 0.5 D for both spherical equivalent and cylinder for 1 year prior to implantation).
  • The Visian TICL is  for placement in behind the Iris  of an eye with is natural lens intact.

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MONROVIA, Calif.–(BUSINESS WIRE)–Sep. 13, 2018– STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of implantable lenses and companion delivery systems for the eye, is today announcing that the FDA has granted approval of the PMA Supplement for the Visian Toric ICL for the correction of myopia with astigmatism.

This approval represents a meaningful expansion of the Implantable Collamer® Lens (ICL) product line for the correction of refractive error in patients with both myopia and astigmatism which are common conditions in the United States (US). Astigmatism affects approximately 30 percent of the population.1

The ICL in both spherical and toric designs has been associated with significant improvements in quality of life. Patients have described ICL surgery as “life changing” or wished they had opted for the surgery sooner.2 The approval of the Visian Toric ICL is also an important step towards the future availability of advanced ICL models in the US, such as the EVO/EVO+ Toric ICL.

“FDA’s approval of STAAR’s Visian Toric ICL in the U.S. provides an exciting treatment option for myopic patients with astigmatism in search of visual freedom. We are thrilled to be able to offer this lens in the United States and look forward to officially making the Visian Toric ICL available to U.S. surgeons for their patients on November 1st, 2018,” said

Dr. Charles Titone: Charles W. Titone, M.D. is Board certified in Ophthalmology, licensed in North Carolina, New York and Florida. Dr Titone attended Howard University College of Medicine as one of handful of 6 year BSMD students and graduated Magna Cum Laude in 1984. He is a member of The American Academy of Ophthalmology and, The American Society of Cataract and Refractive Surgeons.
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