Document ID: FDA-2013-N-0001-0115
Agency: fda
Document Type: Notice
Title: Ophthalmic Devices Panel of the Medical Devices Advisory Committee;
Notice of Meeting
Posted Date: 2013-12-24T05:00Z

[Federal Register Volume 78, Number 247 (Tuesday, December 24, 2013)]
[Notices]
[Pages 77688-77689]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30579]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Ophthalmic Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Ophthalmic Devices Panel of the Medical Devices 
Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on February 14, 2014, from 
8 a.m. to 6 p.m.
    Location: Gaithersburg Marriott Washingtonian Center, Salons A, B, 
C and D, 9751 Washingtonian Blvd., Gaithersburg, MD 20878.
    Contact Person: James Swink, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm.1609, Silver Spring, MD 20993, James.Swink@fda.hhs.gov, 301-796-
6313, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-
443-0572 in the Washington, DC area). A notice in the Federal Register 
about last minute modifications that impact a previously announced 
advisory committee meeting cannot always be published quickly enough to 
provide timely notice. Therefore, you should always check the Agency's 
Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and 
scroll down to the appropriate advisory committee meeting link, or call 
the advisory committee information line to learn about possible 
modifications before coming to the meeting.
    Agenda: On February 14, 2014, 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.''
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will

[[Page 77689]]

be made publicly available at the location of the advisory committee 
meeting, and the background material will be posted on FDA's Web site 
after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the 
appropriate advisory committee meeting link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
February 7, 2014. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. on February 14, 2014. Those 
individuals interested in making formal oral presentations should 
notify the contact person and submit a brief statement of the general 
nature of the evidence or arguments they wish to present, the names and 
addresses of proposed participants, and an indication of the 
approximate time requested to make their presentation on or before 
January 30, 2014. Time allotted for each presentation may be limited. 
If the number of registrants requesting to speak is greater than can be 
reasonably accommodated during the scheduled open public hearing 
session, FDA may conduct a lottery to determine the speakers for the 
scheduled open public hearing session. The contact person will notify 
interested persons regarding their request to speak by February 3, 
2014.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact AnnMarie Williams at 
Annmarie.Williams@fda.hhs.gov or 301-796-5966, at least 7 days in 
advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app.2).

    Dated: December 17, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-30579 Filed 12-23-13; 8:45 am]
BILLING CODE 4160-01-P