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 and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Crystalens™ Model AT-45 Accommodating Posterior Chamber Intraocular Lens (IOL)
Applicant: eyeonics, inc.
Address: 6 Journey, Suite 125, Aliso Viejo, CA 92656
Approval Date: November 14, 2003
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030002a.pdf
What is it? The Model AT-45 is an artificial lens used to correct the visual impairment of aphakia (absence of the natural eye lens) after cataract surgery. It is the first IOL intended to restore a patient’s ability to see objects far away and near without the use of contacts or eye glasses.
This device is a modified plate haptic lens (responsive to muscle movement) with hinges connecting two plates on the sides of the lens. The lens and plate parts of the Model AT-45 are made of silicone and held in the eye by plastic loops.
How does it work? Once the cataract (clouded natural eye lens) is removed from the eye, an intraocular lens (artificial lens) is implanted. This lens is placed inside the thin capsule of tissue (capsular bag) where the natural lens of the eye has been removed.
Illustration of an eye before and after cataract surgery:
The Model AT-45 works much like the natural eye lens. This device helps the patient focus on objects by moving back and forth along the axis of the eye in response to the movement of eye muscles.
When is it used? The Model AT-45 is used in adult patients who have had cataracts removed.
What will it accomplish? The Model AT-45 reduces a patient’s need to wear contacts or eye glasses to see far away and near. This device was shown to successfully restore 20/40 vision, or better, far away vision and near point vision in approximately 88.4% of patients in a clinical study, compared to 35.9% of patients who were implanted with a standard IOL.
When should it not be used? The patient and surgeon should consider the potential risks and benefits in deciding whether or not to implant this device. A surgeon may choose not to use this device if:
- there is inflammation/infection in the eye,
- removing the cataract was especially difficult, or
- there is a defect in the eye that would not allow normal placement of the lens.
These warnings are the same as those for other intraocular lenses.
Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p030002