March 14, 2014 8:00 a.m. to 6:00 p.m.: Ophthalmic Devices Panel of the Medical Devices Advisory Committee.
March 14, 2014 8:00 a.m. to 6:00 p.m.: Ophthalmic Devices Panel of the Medical Devices Advisory Committee
Hilton Washington, DC/North
620 Perry Pkwy.
Gaithersburg, MD 20877
Please click HERE to access the FDA meeting materials associated with this meeting. In the meeting materials, you will find the original meeting announcement, the agenda, committee roster(s), webcast information, FDA proposed questions and other relevant briefing information.
You can access the current roster of the Ophthalmic Devices Panel HERE.
During this meeting, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Visian Toric Implantable Collamer Lens (TICL) sponsored by STAAR Surgical Company. “Visian TICL proposed indications for use:
• For adults 21-45 years of age;
• For correction of myopic astigmatism in adults with spherical equivalent ranging from 3.0D to ≤ 15.0D with cylinder of 1.0D to 4.0D;
• For the reduction of myopic astigmatism in adults with spherical equivalent ranging from greater than 15.0D to 20.0D with cylinder 1.0D to 4.0D;
• With an anterior chamber depth (ACD) of 3.0 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens and a stable refractive history (within 0.5 Diopter for 1 year prior to implantation); and
• The Visian TICL is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye.”
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