FDA approved this device under the Humanitarian Device Exemption (HDE) program. 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.accessdata.fda.gov/cdrh_docs/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:
- can achieve functional vision on a daily basis using contact lenses
- are younger than 21 years of age,
- do not have clear central corneas, and
- have a corneal thickness less than 450 microns at the proposed incision site
SSPB and Labeling: The SSPB will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=h040002.