The Food and Drug Administration (FDA) has approved TECNIS Eyhance™ and TECNIS Eyhance™ Toric II intraocular lens (IOL) for the treatment of cataract patients.
The TECNIS Eyhance IOL is indicated for the visual correction of aphakia in adults who have had cataractous lens removed by extracapsular cataract extraction. The TECNIS Eyhance Toric II IOL is approved for the visual correction of aphakia and pre-existing corneal astigmatism of 1 diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire reduction in residual refractive cylinder. The TECNIS Simplicity® Delivery System is used to fold and assist in inserting both lenses; the lenses are placed in the capsular bag.
The new approvals are the latest in Johnson & Johnson’s IOLs; the Company claims the new TECNIS Eyhance IOL can slightly extend the depth of focus and deliver better image contrast. The safety and effectiveness of the TECNIS Eyhance IOL have not been substantiated in clinical trials and the effects of the optical design on quality of vision, contrast sensitivity, and subjective visual disturbances (glare, halo, etc.) have not been evaluated clinically. Data on efficacy were extrapolated from a clinical study evaluating the Sensar® 1-Piece Lens, which is considered the material and mechanical parent lens of TECNIS Eyhance IOL.
The Directions for Use lists patient circumstances that should be considered when weighing the risks/benefits of treatment.
Both lenses are now commercially available in the US.
- Johnson & Johnson Vision Receives FDA Approval For Next Generation Monofocal Intraocular Lens – TECNIS Eyhance™ And TECNIS Eyhance™ Toric II IOLs – For The Treatment Of Cataract Patients. [Press release]. Santa Ana, CA: Johnson & Johnson; February 2, 2021.
- TECNIS Eyhance Revision Date: 01/2021 TM IOL with TECNIS Simplicity™. Johnson & Johnson. https://www.jnjvisionpro.com/sites/us/files/public/surgical/IOLs/z311524e_a_tecnis_eyhance_iol_with_tecnis_simplicity_delivery_system_us_dfu.pdf Accessed February 4, 2021