The US Food and Drug Administration has approved the TECNIS PureSee intraocular lens for use in cataract surgery, according to a press release from Johnson & Johnson. The device is an extended depth of focus intraocular lens designed to address cataract-related vision loss while mitigating presbyopia.
Cataracts develop with aging and can impair daily activities such as reading, driving, and recognizing faces. Cataract surgery is one of the safest and most commonly performed procedures worldwide and offers patients removal of a clouded natural lens along with the opportunity to enhance vision.
The TECNIS PureSee intraocular lens (IOL) provides extended depth of focus intended to reduce the impact of presbyopia, supporting distance and intermediate vision with some near vision capability. Presbyopia occurs when the eye gradually loses the ability to see objects clearly up close.
According to the company, the TECNIS PureSee IOL is the first US Food and Drug Administration-approved extended depth of focus IOL without a warning related to loss of contrast sensitivity. Contrast sensitivity describes the ability to differentiate an object from its background and plays an important role in visual quality, particularly under low-light conditions. Aspheric monofocal IOLs are widely considered the benchmark for maintaining contrast sensitivity, and the TECNIS PureSee IOL maintained contrast sensitivity comparable with an aspheric monofocal IOL in clinical evaluation.
According to the press release, 97% of patients reported no very bothersome visual disturbances, such as halos or glare, following implantation of the TECNIS PureSee IOL. In addition, 97% of patients indicated they would recommend the lens to friends or family members.
The TECNIS PureSee IOL is based on the TECNIS platform and incorporates proprietary material. Compared with an aspheric monofocal IOL, the device provides improved intermediate visual acuity while maintaining comparable distance visual acuity.
The lens is indicated for implantation in adult patients following removal of a cataractous lens to correct aphakia and address presbyopia. A toric version is also available for patients with greater than or equal to one diopter of preoperative corneal astigmatism.
The TECNIS PureSee IOL will become available in the US later in 2026. The company also reported that nearly half a million eyes worldwide have received the lens following cataract surgery.
Source: Johnson & Johnson
