TECNIS Synergy™ Intraocular Lens (IOL) (Model ZFR00V), TECNIS Synergy™ Toric II IOL (Models ZFW150, ZFW225, ZFW300, ZFW375), TECNIS Synergy™ IOL with TECNIS Simplicity™ Delivery System (Model DFR00V), TECNIS Synergy™ Toric II IOL with TECNIS Simplicity™ Delivery System (Models DFW150, DFW225, DFW300, DFW375) – P980040/S124
Product Name: TECNIS Synergy™ Intraocular Lens (IOL) (Model ZFR00V)
TECNIS Synergy™ Toric II IOL (Models ZFW150, ZFW225, ZFW300, ZFW375)
TECNIS Synergy™ IOL with TECNIS Simplicity™ Delivery System (Model DFR00V)
TECNIS Synergy™ Toric II IOL with TECNIS Simplicity™ Delivery System (Models DFW150, DFW225, DFW300, DFW375)
PMA Applicant: Johnson & Johnson Surgical Vision, Inc.
Address: 1700 East Saint Andrew Place, Santa Ana, CA 92705 USA
Approval Date: April 28, 2021
Approval Letter: Approval Order
What is it?
The TECNIS Synergy™ Intraocular Lenses (IOLs) are artificial lenses implanted in the eyes of adults to correct vision after the natural lenses have been removed due to cataracts. Cataracts, or cloudiness of the natural lens, are often the result of aging, but can have other causes. The TECNIS Synergy™ IOLs are intended to improve the ability to see far away (long distance vision). These lenses also are intended to improve the ability see at an arm’s length distance (intermediate vision) such as working on a computer, applying makeup, or shaving; and at close range (near vision) such as reading, writing, and sewing.
The toric version of these lenses also helps correct a cornea that has a different shape than normal (astigmatism).
How does it work?
The TECNIS Synergy™ IOLs work by bending light rays to allow them to focus on the back surface of the eye, or retina. These lenses are multifocal, that can focus light from objects at multiple distances such as far away, intermediate distances, and close up. People implanted with a multifocal IOL may have less need to wear eyeglasses to see at several distances.
This is different than a typical or conventional monofocal IOL that focuses light from objects only far away. People who receive monofocal lens implants generally need glasses to clearly see objects that are close.
When is it used?
The TECNIS Synergy™ IOLs are used in adult patients during surgery to remove cataracts.
The toric models are used in people with pre-existing corneal astigmatism, or an abnormal curve of the eye greater than or equal to 1 diopter, a standard unit of lens power.
What will it accomplish?
The safety and effectiveness of the TECNIS Synergy™ IOLs was studied in a randomized, controlled clinical trial. One hundred and thirty-five people received TECNIS Synergy™ IOLs and 137 received a monofocal IOL. Vision testing was performed for both groups.
Six months after surgery, people who had their cataracts removed and replaced with TECNIS Synergy™ lenses reported better visual acuity, or sharpness of vision, at near and intermediate distances, when compared to the people who received monofocal IOLs. The TECNIS Synergy™ group also reported less need for eyeglasses than the monofocal IOL group.
When should it not be used?
There are no known specific situations where use of these lenses would be considered harmful.
Additional information (including warnings, precautions, and adverse events):
- Summary of Safety and Effectiveness Data (SSED)
- Patient Labeling
- Physician Labeling Part 2
- PMA Database Entry