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U.S. Department of Health and Human Services

Medical Devices

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EC-3 Posterior Chamber Intraocular Lenses (IOLs), Models EC-3 and EC-3 Precision Aspheric Lens (PAL) - P100016

Photo of the deviceThis 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: EC-3 Posterior Chamber Intraocular Lenses (IOLs), Models EC-3 and EC-3 Precision Aspheric Lens (PAL)
PMA Applicant:
Aaren Scientific, Inc.
Address:
4290 East Brickell Street, Building A, Ontario, CA 91761-1569
Approval Date:
October 19, 2010
Approval Letter:
http://www.accessdata.fda.gov/cdrh_docs/pdf10/p100016a.pdf

What is it? The EC-3 Posterior Chamber IOLs (Models EC-3 and EC-3 PAL) are artificial lenses 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.

The only difference between the EC-3 and EC-3 PAL IOLs is that the EC-3 PAL IOL is manufactured with a minor change to the shape of the circular portion of the IOL.

How does it work? The EC-3 Posterior Chamber IOLs act in place of the healthy eye lens to correctly focus light on the retina and restore vision.

When is it used? The EC-3 Posterior Chamber IOLs are used to restore vision in adult patients who have had a cataract removed.

What will it accomplish? The EC-3 Posterior Chamber IOLs restore vision by acting as a substitute for the removed natural lens.

When should it not be used? The EC-3 Posterior Chamber IOLs 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.

Other Resources: