This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Softec HD Aspheric Posterior Chamber Intraocular Lens
PMA Applicant: Lenstec, Inc.
Address: 1765 Commerce Ave N, St. Petersburg, Florida 33716
Approval Date: April 12, 2010
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf9/P090022a.pdf
What is it? The Softec HD posterior chamber intraocular lens (IOL) is an artificial lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. A cataract is a gradual thickening, hardening and clouding of the eye's lens, resulting in loss of vision. Cataracts are often the result of aging, but can have other causes.
How does it work? The Softec HD IOL acts in place of the healthy eye lens to correctly focus light on the retina and restore vision.
When is it used? The Softec HD IOL is used to restore vision in adult patients who have had a cataract removed.
What will it accomplish? The Softec HD IOL restores vision by acting as a substitute for the removed natural lens.
When should it not be used? The Softec HD IOL should not be implanted when the IOL may worsen an existing condition, interfere with the diagnosis or the treatment of a condition, or present a risk to the sight of the patient.
Additional information: Summary of Safety and Effectiveness and labeling are available online.