Announcement • 2h
Johnson & Johnson Expands U.S. Availability of TECNIS PureSee IOL, an Advanced Lens Option for Cataract Surgeons and Patients
Johnson & Johnson expanded U.S. availability of TECNIS PureSee IOL, an extended depth of focus (EDOF) lens designed to support visual clarity and quality for patients undergoing cataract surgery. 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. 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. 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. TECNIS PureSee IOL addresses both cataract-related vision loss and the effects of presbyopia, which occurs when eyes gradually lose the ability to see objects clearly up close. Nearly everyone will get presbyopia by the age of 50. TECNIS PureSee IOL achieved a 1.5-line difference in mean monocular distance-corrected near VA at 6 months compared to TECNIS 1-Piece. In clinical evaluation, TECNIS PureSee IOL demonstrated contrast sensitivity comparable to an aspheric monofocal intraocular lens, with no clinically meaningful differences (=0.3 log units) versus aspheric monofocal controls across pupil sizes, while maintaining distance visual acuity and low levels of visual symptoms. Over half a million eyes worldwide have already experienced clearer, extended range of vision with TECNIS PureSee IOL after cataract surgery. 97% of patients would recommend TECNIS PureSee IOL to friends or family. 97% of patients reported no very bothersome visual disturbances. TECNIS PureSee IOL provides excellent distance and intermediate vision with some near vision. TECNIS PureSee IOL is indicated for primary implantation for the 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. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the TECNIS PureSee IOL provides improved intermediate visual acuity, while maintaining comparable distance visual acuity. The lens is intended for capsular bag placement only. The TECNIS SIMPLICITY Delivery System is used to fold and assist in inserting the TECNIS PureSee Toric II IOLs, which are indicated for primary implantation for the visual correction of aphakia and for reduction of refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed. The lenses mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the TECNIS PureSee Toric II IOLs provide improved intermediate visual acuity, while maintaining comparable distance visual acuity. The lenses are intended for capsular bag placement only. Physicians should weigh the potential benefit/risk ratio of IOL implantation in patients with any of the conditions listed below, as intraocular lenses may exacerbate an existing condition or may pose an unreasonable risk to the eyesight of patients. The following conditions are not specific to the design of the IOL and are attributed to cataract surgery and/or IOL implantation in general: Recurrent severe anterior or posterior segment inflammation of unknown etiology, Posterior segment diseases of which monitoring or treatment ability may be limited by an intraocular lens, Surgical difficulties at the time of cataract extraction and/or intraocular lens implantation that might increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure, or significant vitreous prolapse or loss), Compromised posterior capsule or zonules due to previous trauma or developmental defect in which appropriate support of the IOL is not possible, Risk of damage to the endothelium during implantation, Suspected microbial infection, Congenital bilateral cataracts, Previous history of, or a predisposition to, retinal detachment, Potentially good vision in only one eye, Medically uncontrollable glaucoma, Corneal endothelial dystrophy, Proliferative diabetic retinopathy. Rotation of the toric lens away from its intended axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, lens repositioning should occur as early as possible prior to lens encapsulation. Do not attempt to disassemble, modify or alter the delivery system or any of its components, as this can significantly affect the function and/or structural integrity of the design. Do not use if the cartridge of the delivery system is cracked or split prior to implantation. Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the delivery system. Do not stop, reverse or advance the plunger too slowly (for example more than 1 second) during initial lens advancement. Doing so may result in improper folding of the lens. Do not advance the lens from the Holding Position prior to fully hydrating the system. A minimum of 1 minute at the Holding Position is required to fully hydrate the system to prevent sticking and a potential scratch or crack to the lens. Do not advance the lens from the Holding Position until ready for implantation. Interruptions during delivery may result in the lens being scratched or cracked or stuck in the cartridge. Discard the device if the lens has been advanced past the Holding Position but not delivered within 60 seconds. The lens and delivery system should be discarded if the lens has been folded within the cartridge for more than 10 minutes. Not doing so may result in the lens being stuck in the cartridge. Johnson & Johnson Surgical Vision Inc., single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. When used according to the directions for use, the delivery system minimizes the risk of infection and/or inflammation associated with contamination. The reuse/resterilization/reprocessing of Johnson & Johnson Surgical Vision Inc. single-use medical devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient contamination, transmission of infection, and lack of product sterility.