FDA clears J&J's TECNIS PureSee IOL
Johnson & Johnson announced FDA approval for the TECNIS PureSee intraocular lens, an extended‑depth‑of‑focus IOL that clinicians report produced no bothersome visual disturbances in 97% of trial patients. The approval strengthens J&J’s vision portfolio at a time when refractive solutions are a key growth driver as populations age.
Johnson & [Johnson said]jnj.com in a March 12, 2026 press release that the TECNIS PureSee lens is slated to be available in the U.S. later in 2026. The pivotal randomized trial registered as [NCT05574959 enrolled]clinicaltrials.gov 243 patients across 10 U.S. sites and lists a primary completion date of October 24, 2023. A peer‑reviewed Eye (Nature) paper from [2024 reported]nature.com a randomized cohort (test N=60 versus control N=57) showing statistically superior intermediate and near acuity for the test lens with mesopic contrast sensitivity differing by no more than 0.11 log units. Johnson & [Johnson positions]jjvision.com PureSee as the first U.S. EDOF IOL cleared without a contrast‑sensitivity warning, and company materials show multicenter real‑world data [were presented]jnjmedtech.com at ESCRS in September 2025.
