Johnson & Johnson Expands Full U.S. Commercial Availability of TECNIS PureSee EDOF IOL for Cataract Surgery
核心洞察
Johnson & Johnson has expanded full U.S. commercial availability of the presbyopia (搜索)-correcting TECNIS PureSee intraocular lens following its FDA approval in March.
The TECNIS PureSee is the first and only FDA-approved extended-depth-of-focus IOL with no warning on loss of contrast sensitivity, offering a monofocal-like visual disturbance profile.
Clinical data show 97% of patients would recommend the lens to friends and family, with maintained contrast sensitivity and tolerance to refractive error.
Johnson & Johnson is expanding full commercial availability of the TECNIS PureSee intraocular lens (IOL) across the United States, the company announced, broadening access to the presbyopia (搜索)-correcting extended-depth-of-focus (EDOF) lens that received FDA approval in March of this year.
"With the full U.S. availability of Tecnis PureSee IOL (搜索), we are expanding access to an important extended depth of focus option that reflects our commitment to innovation, visual quality and patient satisfaction," said Erin Powers, president of surgical vision, North America, Johnson & Johnson, in the press release. "Patients today want vision solutions that support how they live their lives every day. Tecnis PureSee IOL builds on the trusted Tecnis platform to help meet those expectations while giving surgeons greater flexibility to personalize care."
Indications and Design Features
The TECNIS PureSee IOL (搜索) is indicated for primary implantation for the visual correction of aphakia (搜索) in adult patients aged 22 and older with less than 1 diopter of pre-existing corneal astigmatism in whom a cataractous lens has been removed. The lens is intended solely for capsular bag placement and addresses both cataract (搜索)-related vision loss and the effects of presbyopia (搜索).
According to Johnson & Johnson, the TECNIS PureSee holds a distinctive regulatory position: it is the first and only FDA-approved EDOF IOL with no warning on loss of contrast sensitivity. The lens delivers a monofocal-like visual disturbance profile, maintained contrast sensitivity, distance and intermediate vision with some near range, and demonstrated tolerance to refractive error.
Clinical Outcomes and Patient Satisfaction
Previous research cited by the company indicates strong patient satisfaction with the lens. According to the press release, 97% of patients reported that they would recommend the IOL to their friends and family. The lens is implanted using the TECNIS SIMPLICITY Delivery System.
Patient Decision-Support Tool
Coinciding with Cataract (搜索) Awareness Month, Johnson & Johnson is also rolling out a lifestyle quiz called the "TECNIS IOL Selection Tool." The survey includes questions about patients' daily routines, comfort with glasses, and nighttime driving habits. The company stated that patients can use the quiz as a starting point to consider their vision goals before meeting with a surgeon, serving as a first step in patient education and facilitating informed discussions with eyecare providers about IOL options.