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: TECNIS Multifocal 1-Piece Intraocular Lens (IOL), Models ZKB00 (+2.75 D) and ZLB00 (+3.25 D)
PMA Applicant: Abbott Medical Optics, Inc.
Address: 1700 East Saint Andrew Place, Santa Ana, CA 92705-9433
Approval Date: December 17, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/p980040s049a.pdf
What is it? TECNIS Multifocal IOLs, Models ZKB00 and ZLB00, are artificial lenses. The IOL is implanted inside the eye to replace the natural lens after its removal due to clouding (cataract). Cataracts are often the result of aging, but can have other causes.
How does it work? TECNIS Multifocal IOLs, Models ZKB00 and ZLB00, focus light inside the eye to provide a range of vision from distance to near.
When is it used? TECNIS Multifocal IOLs, Models ZKB00 and ZLB00, are used in adult patients, 22 years and older, following cataract surgery.
What will it accomplish? In a clinical study, the TECNIS Multifocal IOLs, Models ZKB00 and ZLB00, were shown to provide distance, intermediate, and near vision to patients who have undergone cataract surgery.
When should it not be used? There are no known contraindications.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.
