EDoF intraocular lens TECNIS PureSee™ IOL

Overview
The TECNIS PureSee™ IOL is a purely refractive extended depth-of-focus (EDOF) intraocular lens engineered to provide improved intermediate visual acuity while maintaining distance visual performance comparable to an aspheric monofocal IOL. The lens is supplied preloaded with the TECNIS SIMPLICITY™ Delivery System for primary implantation following cataract extraction.

Key Features

• Monofocal-like visual disturbance profile (monofocal-like dysphotopsia)
• Maintained image contrast and contrast sensitivity relative to some comparator EDOF technologies
• Extended depth-of-focus providing improved intermediate vision and some near vision
• Tolerance to defocus, supporting high patient satisfaction in clinical evaluations

Clinical Highlights

• Approximately 90% of patients reported occasionally or never wearing glasses at 6 months (none/a little/some of the time) in clinical evaluation
• 97% of patients would recommend the lens to friends or relatives in a prospective randomized multicenter 6-month study (N=66)
• 97% of patients reported no very bothersome visual disturbances in study assessment

Indications for Use
The TECNIS PureSee™ IOL (including TECNIS PureSee™ Toric II variants) with the TECNIS SIMPLICITY™ Delivery System is indicated for primary implantation for visual correction of aphakia in adults after cataract extraction. Toric II IOLs are indicated for reduction of preoperative corneal astigmatism ≥1.0 D. Lenses provide extended depth of focus and are intended for capsular bag placement only. Prescription only.

Selected WARNINGS (summary)

• Assess benefit/risk in patients with recurrent severe inflammation, posterior segment disease, prior ocular trauma, or compromised posterior capsule or zonules.
• Rotation of toric lenses away from the intended axis may reduce astigmatic correction; misalignment greater than 30° can increase residual cylinder — reposition early if needed.
• Do not disassemble, modify, or alter the delivery system or its components.
• Do not use if delivery system cartridge is cracked or split prior to implantation.
• Do not implant the lens if the rod tip does not advance the lens or is jammed in the delivery system.
• Follow specified hydration, holding-position, and delivery timing to avoid lens sticking, scratching, cracking, or improper folding; discard device if folded in cartridge for more than 10 minutes.
• Single-use device: reuse, resterilization or reprocessing may damage the device or increase risk of infection; do not reuse.

Selected PRECAUTIONS (summary)

• Surgeon must inform prospective patients of potential risks and benefits and provide the patient information brochure before surgery.
• Autorefractors may not provide optimal postoperative refraction; manual refraction using maximum plus technique is strongly recommended.
• Do not resterilize or autoclave the delivery system.
• Do not store in direct sunlight or outside the recommended temperature range (5°C–35°C / 41°F–95°F).
• Recommended implantation temperature at least 17°C (63°F).
• Use balanced salt solution or ophthalmic viscosurgical devices (OVDs) when using the delivery system; HEALON™ family is recommended for OVD.
• Lens must be placed entirely in the capsular bag and not in the ciliary sulcus; remove all viscoelastic and avoid over‑inflation of the bag to reduce risk of rotation.
• Careful preoperative evaluation is required for patients with prior corneal refractive surgery, unstable refraction, or other contraindications; children under age 2 are not suitable candidates.

Footnotes & Evidence
Clinical and bench references are provided by the manufacturer, including a prospective randomized multicenter 6-month clinical study (N=66) for patient-reported outcomes and optical bench testing (DOF2023CT4012). See full Directions for Use and labeling for complete study citations and data.

Technical specifications

• Commercial name: TECNIS PureSee™ IOL
• Model referenced in labeling: DEN00V (manufacturer model identifier)
• Delivery system: TECNIS SIMPLICITY™ Delivery System (preloaded)
• Intended use: Primary implantation for visual correction of aphakia after cataract extraction; Toric II IOLs indicated for reduction of preoperative corneal astigmatism (≥1.0 D)
• Intended placement: Capsular bag only
• Device type: Preloaded intraocular lens with single-use delivery system; sterile
• Design: Purely refractive extended depth-of-focus (EDOF) IOL engineered for monofocal-like dysphotopsia profile and extended intermediate vision
• Clinical evidence highlights: prospective randomized multicenter 6-month study (N=66) reporting high patient satisfaction and spectacle independence metrics
• Optical bench testing reference: DOF2023CT4012
• Regulatory/label note: Prescription only; consult Directions for Use for complete indications, warnings, precautions and potential complications associated with cataract surgery and IOL implantation