This is a brief overview of information pertaining to FDA’s approval to market this product. Please find below a brief summary about the product as well as product labelling and even more detailing on this item, its indicators for usage, and the basis for FDA’s approval.
Item Call: AcrySof ® INTELLIGENCE PanOptix ® Trifocal Intraocular Lens (Design TFNT00) and AcrySof ® IQ PanOptix ® Toric Trifocal Intraocular Lens (Models TFNT30, TFNT40, TFNT50, TFNT60). PMA Candidate: Alcon Laboratories, Inc
Authorization Date: August 26, 2019.
What is it?
The AcrySof ® INTELLIGENCE PanOptix ® Trifocal Intraocular Lens (Version TFNT00) as well as AcrySof ® IQ PanOptix ® Toric Trifocal Intraocular Lens (Models TFNT30, TFNT40, TFNT50, TFNT60) are synthetic lenses (Intraocular lens, IOL) which are the artificial lenses for the eyes.. Cataracts (cloudiness of the all-natural lens) are frequently due to the result of aging, yet can have various other causes. The AcrySof ® IQ PanOptix ® Toric IOL is an aritificial lens implant that is made use of to improve vision after cataract elimination in people that have blurred vision due to an irregularly designed cornea (corneal astigmatism).
This approval broadens the use to offer enhanced intermediate clear vision (for example, using a computer, using make-up or shaving) as well as near clear vision (for example, analysis, creating, and also embroidery).
How does it work?
The AcrySof ® IQ PanOptix ® Trifocal Intraocular Lens (Version TFNT00) as well as AcrySof ® INTELLIGENCE PanOptix ® Toric Trifocal Intraocular Lens (Designs TFNT30, TFNT40, TFNT50, TFNT60) functions by activating light rays to enable them to focus on the retina (the back surface of the eye) to attend to enhanced distance (as an example, driving, playing golf etc.), intermediate, and near vision.
When is it made use of?
The AcrySof ® INTELLIGENCE PanOptix ® Trifocal Intraocular Lens is implanted in individuals 22 years of age or older, with less than 1 diopter of pre-existing corneal astigmatism, and have actually had cataract surgical procedure.
What will it achieve?
The AcrySof ® INTELLIGENCE PanOptix ® Trifocal Intraocular Lens minimizes the results of presbyopia (inability to concentrate on close images, such as reading) by giving improved intermediate and close to clear vision, while maintaining comparable range clear vision with a decreased demand for glasses, contrasted to a monofocal (one focusing distance) IOL, where external glasses or spectacles will invariably be, additionally needed.
In a scientific study of 243 people implanted with either the PanOptix lens or a control lens, an overall of 129 patients (256 eyes) were implanted with the PanOptix lens (127 in both eyes), as well as 2 patients in one eye. A total of 114 individuals (225 eyes) were implanted with the control lens (111 in both eyes, 3 in one eye).
After 6 months of implantation, the ordinary best fixed distance with clear vision in one eye examined was approximately 20/20 for each and every study group. For intermediate range, clear vision in one eye with the PanOptix lens was around 20/25 compared to 20/40 for the control team. The clear vision for near distance modification with the PanOptix lens was about 20/25, contrasted to 20/63 for the control group. In general, there were no safety and security issues throughout the research.
When should it not be utilized?
There are no well-known reasons for not having the PanOptix lens implanted.
Additional information (consisting of warnings, precautions, as well as adverse events):Summary of Security and also Performance Data (SSED) and labelling are available online at:
– Recap of Safety as well as Efficiency Information
– Person Classifying
– Physician Labelling
– PMA Data Source Entrance