FDA Approves TECNIS PureSee Lens for Cataract Surgery

Johnson & Johnson has received approval from the U.S. Food and Drug Administration for its TECNIS PureSee intraocular lens (IOL), a new extended depth of focus (EDOF) lens designed for use in cataract surgery. The company said the lens will become available to patients in the United States later this year, offering surgeons another option for restoring vision while addressing age-related visual decline.

The newly approved TECNIS PureSee IOL is designed to provide patients with a broader range of vision while minimizing common visual disturbances that can occur with certain lens technologies. According to clinical data cited by the company, approximately 97% of patients reported no very bothersome visual disturbances after receiving the lens.

Peter Menziuso, Company Group Chairman for Vision at Johnson & Johnson, described the approval as an important milestone for patients living with cataracts. He noted that cataract surgery is often a once-in-a-lifetime opportunity for patients to restore and improve their vision, and the addition of the TECNIS PureSee IOL expands the company’s ability to offer personalized vision solutions tailored to patients’ lifestyle needs.

Cataracts occur naturally as the eye’s lens becomes cloudy with age, making everyday activities such as reading, driving, or recognizing faces increasingly difficult. Cataract surgery is among the most commonly performed medical procedures worldwide and involves removing the clouded natural lens and replacing it with an artificial intraocular lens. In many cases, the procedure not only restores vision but also improves overall visual performance.

The TECNIS PureSee IOL is designed to address both cataract-related vision loss and Presbyopia—an age-related condition that gradually reduces the ability to focus on nearby objects. By offering extended depth of focus, the lens allows patients to achieve strong distance and intermediate vision, while also providing some near-vision capability.

A key feature of the lens is its preservation of contrast sensitivity, an important component of visual clarity that helps individuals distinguish objects from their background. Maintaining strong contrast sensitivity is particularly important in low-light environments or situations such as night driving or foggy conditions. According to Johnson & Johnson, the TECNIS PureSee IOL is currently the only FDA-approved EDOF intraocular lens without a warning related to loss of contrast sensitivity.

The lens is built on the company’s long-established TECNIS platform, which combines advanced optical design with proprietary materials developed over more than two decades of intraocular lens innovation. Johnson & Johnson reports that millions of patients worldwide receive TECNIS lenses each year as part of cataract surgery procedures.

The approval also expands the broader TECNIS portfolio of surgical vision products. This lineup includes the TECNIS Odyssey IOL, designed to provide a full visual range, and the TECNIS Eyhance IOL, a monofocal lens engineered to slightly extend depth of focus beyond traditional monofocal designs.

Globally, the TECNIS PureSee IOL has already been approved in multiple markets, and nearly half a million eyes have been implanted with the lens worldwide. With the new FDA approval, the technology is expected to reach a significantly larger patient population in the United States.

Health experts estimate that about 94 million people aged 50 and older worldwide suffer from moderate-to-severe vision impairment or blindness that could potentially be corrected through lens replacement surgery. Innovations in intraocular lens technology, such as extended depth of focus designs, are aimed at improving outcomes and reducing patients’ reliance on glasses after surgery.

With the introduction of TECNIS PureSee IOL in the U.S., Johnson & Johnson is positioning itself to further strengthen its presence in the surgical vision market while expanding options for patients seeking improved vision following cataract surgery.

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