02.02.21

Johnson & Johnson Vision Receives FDA Approval For Tecnis Eyhance and Tecnis Eyhance Toric II Monofocal IOLs

Source: Johnson & Johnson Vision

Johnson & Johnson Vision announced that the FDA has approved the Tecnis Eyhance and Tecnis Eyhance Toric II IOLs in the United States. The first implantation of Tecnis Eyhance IOL in the US will happen in Texas next week.

“Eighty-four percent of surgeons7 choose monofocal IOLs for their cataract patients, so it’s thrilling to see the first breakthrough in monofocal technology in decades enter the market to add to our treatment portfolio,” Douglas Koch, MD, Houston, Texas, said in a company news release. “It’s the first monofocal designed to provide a slight increase in the depth of focus,1,8 which is something I need for the patients in my practice looking for more from a monofocal.”

The latest innovation in the Tecnis family of IOLs—Tecnis Eyhance and Tecnis Eyhance Toric II IOLs—are defining the future of monofocals, with a breakthrough refractive surface designed to:

  • Slightly extend the depth of focus1* through the unique shape of the lens
  • Deliver better image contrast in low light9 Tecnis Eyhance IOLs deliver 30% improvement in image contrast compared to AcrySof IQ SN60WF at 5mm
  • Provide safe and easy delivery using the new Tecnis Simplicity system that streamlines lens delivery and protects against contamination10

“Built on the proven Tecnis platform,11 Tecnis Eyhance combines low-light performance with breakthrough refractive surface design, providing a new kind of monofocal experience for cataract patients,12Rajesh K. Rajpal, MD, Chief Medical Officer and Global Head of Clinical and Medical Affairs at Johnson & Johnson Vision, said in the news release. “Additionally, the Tecnis Eyhance Toric II lens is engineered with a new squared and frosted haptic design for added friction inside the capsular bag to treat cataract patients with astigmatism.”

The Tecnis Eyhance IOL is the latest lens in the Tecnis family, which celebrates its 20th anniversary this year. The Tecnis family portfolio is the broadest mix of IOLs for cataract patients in need of monofocals, multifocals, extended depth of focus (EDOF), and those with or without astigmatism, according to J&J Vision.   

“We consistently engage with our surgeons and their patients to better understand their unmet needs, and their feedback drove us to innovate and push the boundaries of the monofocal category – a category that’s largely been stagnant for the last 20 years,” said Sandor Palfi, Commercial Vice President of the Americas at Johnson & Johnson Vision. “Tecnis Eyhance IOL is built on the foundation of our proven Tecnis platform, designed to deliver more.” 

Tecnis Eyhance first launched in Europe in February 2019 and became commercially available in Latin America and Canada in the summer of 2020. Tecnis Eyhance and Tecnis Eyhance Toric II are now commercially available in the U.S., with Tecnis Eyhance Toric II launching in Europe and Canada later this year.

References

1 Data on file. Eyhance DFU. The TECNIS Eyhance™ IOLs are designed to slightly extend the depth of focus compared to the TECNIS 1-Piece IOL, Model ZCB00 as measured in bench testing.
2 Kellogg Eye Center. Cataract. https://www.umkelloggeye.org/conditions-treatments/cataract.
3 World Health Organization. Blindness and Impairment. https://www.who.int/en/news-room/fact-sheets/detail/blindness-and-visual-impairment
4 Vision Health Initiative, Common Eye Disorders. Centers for Disease Control and Prevention. https://www.cdc.gov/visionhealth/basics/ced/index.html
5 All About Vision. Will I Need Glasses After Cataract Surgery? https://www.allaboutvision.com/conditions/faq-cataract-glasses-after-surgery.htm
6 Khandelwal SS, et. al. Effectiveness of multifocal and monofocal intraocular lenses for cataract surgery and lens replacement: a systematic review and meta-analysis. Graefes Arch Clin Exp Ophthalmol. 2019 May;257(5):863-875. doi: 10.1007/s00417-018-04218-6.
7 Market Scope 2020 Global IOL Report.
8 Data on file. Eyhance DFU.  
9 Data on file. Johnson & Johnson Surgical Vision, Inc. 2021.
10 TECNIS Monofocal IOL with TECNIS Simplicity® Delivery System (package insert, DFU DCB00 (Z311063P Rev. D).
11 The safety and effectiveness of the TECNIS Eyhance™ IOL has not been substantiated in clinical trials. The effects of the TECNIS Eyhance™ IOL optical design on quality of vision, contrast sensitivity, and subjective visual disturbances have not been evaluated clinically.
12 Data on file, Johnson & Johnson Surgical Vision, Inc. 2021.

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