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New Humanitarian Device Approval

INTACS® Prescription Inserts for Keratoconus - H040002

FDA approved this device under the Humanitarian Device Exemption (HDE) program http://www.fda.gov/cdrh/ode/hdeinfo.html. See the links below to the Summary of Safety and Probable Benefit (SSPB) and other sites for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: INTACS® Prescription Inserts for Keratoconus
Manufacturer: Addition Technology, Inc.
Address: 155 Moffett Park Drive, Suite B-1
Sunnyvale, CA 94089-1330
Approval Date: July 26, 2004
Approval Letter: http://www.fda.gov/cdrh/pdf4/h040002a.pdf

What is it?
INTACS® Inserts are two curved, clear plastic segments that are implanted in the perimeter of the cornea to reduce nearsightedness (myopia) and irregular steepening of the cornea (irregular astigmatism) caused by keratoconus.

How does it work?
INTACS® Inserts are implanted through a small surgical incision on the perimeter of the cornea. The inserts help restore clear vision in keratoconus patients by flattening and repositioning the cornea.

When is it used?
INTACS® Inserts are intended for patients with keratoconus who are no longer able to achieve adequate vision using contact lenses or glasses and for whom corneal transplant is the only remaining option.

What will it accomplish?
INTACS® Inserts may restore functional vision and postpone the need for a corneal transplant.

When should it not be used?
INTACS® Inserts should not be used in keratoconus patients who:

Additional information:
SSPB and Labeling: The SSPB will be available at: http://www.fda.gov/cdrh/ode/h040002sum.html.

Information on keratoconus:
http://www.nlm.nih.gov/medlineplus/ency/article/001013.htm

Information on refractive eye disorders:
http://www.nlm.nih.gov/medlineplus/refractiveerrors.html

Information on myopia:
http://www.nlm.nih.gov/medlineplus/ency/article/001023.htm

Information on astigmatism:
http://www.nlm.nih.gov/medlineplus/ency/article/001015.htm

Updated September 21, 2004

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