Johnson & Johnson Secures U.S. Food and Drug Administration Approval for TECNIS PureSee Intraocular Lens, Expanding Vision Care Options for U.S. Cataract Patients
Johnson & Johnson announced U.S. Food and Drug Administration (FDA) approval of TECNIS PureSee IOL, an extended depth of focus (EDOF) intraocular lens (IOL) intended for use in cataract surgery.1 TECNIS PureSee IOL delivers clarity of vision for patients, with 97% of them reporting no very bothersome visual disturbances.1 TECNIS PureSee IOL will be available for patients in the U.S. later this year.
“Today marks an exciting milestone for people living with cataracts. The approval of the TECNIS PureSee IOL gives surgeons an important new lens option, reflecting our deep commitment to innovation that delivers high patient satisfaction and supports vision solutions tailored to individual lifestyle needs,” said Peter Menziuso, Company Group Chairman, Vision, Johnson & Johnson. “Cataract surgery is often a once-in-a-lifetime opportunity for patients to restore and enhance their vision. With the addition of TECNIS PureSee IOL to our portfolio, we can help even more patients regain not just sight, but the quality, range, and visual performance they expect from a Johnson & Johnson product.”
Cataracts naturally form as the eye ages, making everyday activities such as reading, driving, and recognizing faces more difficult. Cataract surgery is one of the safest and most commonly performed procedures worldwide, offering patients the removal of a clouded natural lens and also the opportunity to enhance their vision.3 In a single procedure, TECNIS PureSee IOL addresses both cataract-related vision loss and the effects of presbyopia,1 which occurs when your eyes gradually lose the ability to see objects clearly up close.4 Currently, an estimated 94 million people aged 50 years and over have moderate-to-severe distance vision impairment or blindness that could be corrected through lens replacement surgery.5
TECNIS PureSee IOL is the first and only U.S. FDA‑approved extended depth of focus (EDOF) IOL with no warning on loss of contrast sensitivity.1* Contrast sensitivity refers to a patient’s ability to distinguish an object from its background, an important part of visual quality, especially in low‑light or foggy conditions. Aspheric monofocal IOLs are widely considered the benchmark for preserving contrast sensitivity, and by maintaining contrast sensitivity comparable to an aspheric monofocal IOL, TECNIS PureSee IOL helps patients experience the visual clarity and confidence they expect, while also benefiting from an extended range of vision.1
TECNIS PureSee IOL is built on the industry‑leading TECNIS platform, combining advanced optics with proprietary material. It mitigates the effects of presbyopia by providing extended depth of focus, enabling excellent distance and intermediate vision, with some near vision.1** TECNIS PureSee IOL reduces patients’ reliance on glasses following surgery, with 97% of patients reporting no very bothersome visual disturbances.1,2
TECNIS PureSee IOL expands Johnson & Johnson’s surgical vision portfolio, which is backed by 25 years of innovation in intraocular lens technology. Each year, millions of patients worldwide receive TECNIS lenses as part of their cataract surgery.⁶ The TECNIS portfolio includes TECNIS PureSee IOL, a purely refractive EDOF IOL;1 TECNIS Odyssey IOL, a Full Visual Range (FVR) IOL;⁷ and TECNIS Eyhance IOL, the first monofocal IOL designed to slightly extend depth of focus.⁸
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