Johnson & Johnson Receives FDA Approval for TECNIS PureSee IOL, First Extended Depth of Focus Lens Without Contrast Sensitivity Warning
核心洞察
Johnson & Johnson announced FDA approval of TECNIS PureSee IOL (搜索), the first and only U.S. FDA-approved extended depth of focus intraocular lens with no warning on loss of contrast sensitivity.
Clinical data shows 97% of patients reported no very bothersome visual disturbances like halos or glare, with 97% recommending the lens to friends or family.
The lens addresses both cataract-related vision loss and presbyopia in a single procedure, providing excellent distance and intermediate vision with some near vision capability.
Johnson & Johnson announced U.S. Food and Drug Administration approval of TECNIS PureSee IOL (搜索), an extended depth of focus intraocular lens intended for use in cataract surgery. The approval marks a significant advancement in vision correction technology, as TECNIS PureSee IOL is the first and only U.S. FDA-approved extended depth of focus IOL maintaining contrast sensitivity comparable to an aspheric monofocal IOL.
Clinical Performance and Patient Satisfaction
Clinical evaluation data demonstrates strong patient outcomes with the new lens technology. According to the company, 97% of patients reported no very bothersome visual disturbances, such as halos or glare, with TECNIS PureSee IOL (搜索). Additionally, 97% of patients indicated they would recommend this IOL to friends or family, reflecting high satisfaction rates.
"Today marks an exciting milestone for people living with cataracts. The approval of the TECNIS PureSee IOL (搜索) 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.
Addressing Multiple Vision Challenges
The TECNIS PureSee IOL (搜索) addresses both cataract-related vision loss and the effects of presbyopia in a single procedure. Presbyopia occurs when eyes gradually lose the ability to see objects clearly up close, a natural aging process that affects vision quality. The lens mitigates presbyopia effects by providing extended depth of focus, enabling excellent distance and intermediate vision, with some near vision capability.
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. Cataracts naturally form as the eye ages, making everyday activities such as reading, driving, and recognizing faces more difficult.
Contrast Sensitivity Preservation
A key differentiator of TECNIS PureSee IOL (搜索) is its preservation of contrast sensitivity. Contrast sensitivity refers to a patient's ability to distinguish an object from its background, an important component of visual quality, especially in low-light or foggy conditions. Aspheric monofocal IOLs are widely considered the benchmark for preserving contrast sensitivity.
In clinical evaluation, TECNIS PureSee IOL (搜索) demonstrated contrast sensitivity comparable to an aspheric monofocal intraocular lens, with no clinically meaningful differences versus aspheric monofocal controls across pupil sizes, while maintaining distance visual acuity and low levels of visual symptoms.
Technology Platform and Global Experience
TECNIS PureSee IOL (搜索) is built on the industry-leading TECNIS platform, combining advanced optics with proprietary material. The lens 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.
The lens is already approved globally, and nearly half a million eyes worldwide have already experienced clearer, uninterrupted vision with TECNIS PureSee IOL (搜索) after cataract surgery. TECNIS PureSee IOL will be available for patients in the U.S. later this year.
Clinical Specifications
The TECNIS PureSee IOL (搜索) is indicated for primary implantation for visual correction of aphakia in adult patients with less than 1 diopter of pre-existing corneal astigmatism in whom a cataractous lens has been removed. Compared to an aspheric monofocal IOL, the TECNIS PureSee IOL provides improved intermediate visual acuity while maintaining comparable distance visual acuity. The lens achieved a 1.5-line difference in mean monocular distance-corrected near visual acuity at 6 months compared to TECNIS 1-Piece.
Cataract surgery is one of the safest and most commonly performed procedures worldwide, offering patients the removal of a clouded natural lens and the opportunity to enhance their vision. The TECNIS PureSee IOL (搜索) reduces patients' reliance on glasses following surgery while providing the visual clarity and confidence patients expect from an extended range of vision solution.