Medical Devices

Visian® Toric ICL (Implantable Collamer® Lens) – P030016/S001

Image of Visian® Toric ICL Implantable Collamer® Lens

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Visian® Toric ICL (Implantable Collamer® Lens)
PMA Applicant: STAAR Surgical Company
Address: 1911 Walker Avenue, Monrovia, CA 91016
Approval Date: September 13, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf3/P030016S001a.pdf

What is it?

The Visian® Toric ICL is an artificial lens that is permanently implanted inside the eye behind the iris and in front of the natural lens. The lens is intended to correct nearsightedness (myopia). This approval expands the use to correct blurred vision due to an irregularly shaped cornea (astigmatism). The device does not replace the natural lens.

How does it work?

The Visian® Toric ICL works by bending light rays to allow them to focus on the retina (the back surface of the eye) to provide for clear distance vision.

When is it used?

The Visian® Toric ICL is implanted in patients 21 – 45 years of age, who do not have cataracts and have not required cataract surgery. It is designed for:

  • the correction of myopic astigmatism with less than or equal to -3.0D to less than -15.0D with cylinder of 1.0D to 4.0D at the spectacle plane
  • the reduction of myopic astigmatism ranging from greater than -15.0D to -20.0D with cylinder 1.0D to 4.0D at the spectacle plane
  • with an anterior chamber depth of 3.00 mm or greater, and a stable refractive history within 0.5D for 1 year prior to implantation.

What will it accomplish?

The Visian® Toric ICL may improve distance vision and correct or reduce myopia with astigmatism.

In a clinical study of 210 patient’s eyes implanted with the Visian® Toric ICL, 97.4% of eyes achieved within 1.0 D from target refraction and 97.9% of patients had less than or equal to (10) degrees of lens rotation after one year.

The most common safety event that occurred during the trial was a second surgical procedure to reposition, or remove and replace the lens, which did not result in any significant loss in vision sharpness. Implantation of the device can be associated with risks of cataract formation, increased eye pressure, and second surgical procedure.

When should it not be used?

The Visian® Toric ICL should not be used in patients who:

  • have an anterior chamber depth of less than 3.00 mm as determined by their eye doctor,
  • have an anterior chamber angle less than Grade III as determined by gonioscopic examination,
  • are pregnant or nursing,
  • are younger than 21 years of age,
  • do not meet the minimum endothelial cell density as specified in the labeling.

Additional information (including warnings, precautions, and adverse events):

Summary of Safety and Effectiveness Data (SSED) and labeling are available at:

 

Page Last Updated: 10/04/2018
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