FDA approves J&J’s TECNIS PureSee EDOF IOL for cataract surgery; 97% of patients reported no very bothersome visual disturbances, enhancing vision and reducing glasses need.
Written By: Karthik Teja Macharla, PharmD
Reviewed By: Pharmacally Editorial Team
Johnson & Johnson has received approval from the U.S. Food and Drug Administration (FDA) for TECNIS PureSee, a new extended depth of focus (EDOF) intraocular lens (IOL) designed for patients undergoing cataract surgery. The lens is intended to improve visual range while maintaining visual clarity, with availability in the United States expected later this year.
The TECNIS PureSee IOL is designed to restore vision affected by cataracts while also addressing presbyopia, the age-related loss of near-vision focusing ability. By providing an extended depth of focus, the lens enables strong distance and intermediate vision along with some near vision, potentially reducing patients’ reliance on glasses after surgery.
In clinical evaluations (NCT06377514), 97% of patients reported no very bothersome visual disturbances after implantation of the lens. The device is also the first FDA-approved EDOF intraocular lens without a warning related to loss of contrast sensitivity. Contrast sensitivity is critical for distinguishing objects from their background, particularly in low-light or foggy environments.
“Today marks an exciting milestone for people living with cataracts,” said Peter Menziuso, Company Group Chairman, Vision at Johnson & Johnson. “The approval of TECNIS PureSee gives surgeons an important new lens option that supports vision solutions tailored to individual lifestyle needs. Cataract surgery is often a once-in-a-lifetime opportunity for patients to restore and enhance their vision.”
Cataracts develop gradually with aging and can make everyday activities such as reading, driving, and recognizing faces increasingly difficult. Cataract surgery replaces the clouded natural lens of the eye with an artificial intraocular lens, making it one of the most commonly performed and successful surgical procedures worldwide. An estimated 94 million people aged 50 years and older have moderate-to-severe distance vision impairment or blindness that could be corrected through lens replacement surgery.
TECNIS PureSee is built on the TECNIS intraocular lens platform and uses advanced optical design combined with proprietary materials to extend the range of vision while maintaining contrast sensitivity comparable to traditional aspheric monofocal lenses.
The approval expands Johnson & Johnson’s surgical vision portfolio, which includes TECNIS PureSee, the TECNIS Odyssey full visual range IOL, and TECNIS Eyhance, a monofocal lens designed to slightly extend depth of focus. According to the company, nearly half a million eyes worldwide have already been treated with TECNIS PureSee following its approvals in other regions.
The company expects the lens to become available to patients in the United States later this year.
References
Johnson & Johnson Announces FDA Approval of TECNIS PureSee Intraocular Lens, a Breakthrough Solution for U.S. Cataract Patients, 12 March 2026, Johnson & Johnson Announces FDA Approval of TECNIS PureSee Intraocular Lens, a Breakthrough Solution for U.S. Cataract Patients
Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens, ClinicalTrials.gov ID NCT06377514, https://clinicaltrials.gov/study/NCT06377514
About the Writer
Karthik Teja Macharla, PharmD,
He is a Pharm.D. graduate with a strong interest in clinical research, pharmacovigilance, and medical writing. In his words, he is passionate about converting complex medical information into clear, evidence-based scientific communication, committed to contributing to patient safety and advancing healthcare through accurate and impactful medical content.