Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website
FDA Home Page | CDRH Home Page | Search | A-Z Index U.S. Food and Drug AdministrationCenter for Devices and Radiological Health Questions?
horizonal rule
Consumer (CDRH/FDA) (Consumer Photo Montage)
Skip Consumer NavigationConsumer Home Product Information Choosing a Medical Device How We Can Help Resources Problems with Medical Devices

(See Related Information)
New Humanitarian Device Approval

Diagram of the device. Shows the 150 degree angle of the insert, the positioning holes, and the location of the temporal incision.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) in patients with keratoconus. Keratoconus is a visual disorder that occurs when the normally round and dome-shaped cornea progressively thins, causing a cone-like bulge to develop.

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?
The 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 June 6, 2006

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH