EDoF intraocular lens TECNIS Symfony™

astigmatism

Overview
The TECNIS Symfony™ OptiBlue™ intraocular lens (IOL) is an extended depth-of-focus (EDOF) IOL built on the proven TECNIS™ platform. It provides a continuous range of vision from distance to near using InteliLight™ Technology and is also available in Toric II configurations for reduction of corneal astigmatism.

Key Features

• Continuous range of vision: Mean visual acuity of approximately 20/32 or better from infinity to <20 inches (study data).
• Pupil independence: Consistent optical performance across lighting conditions.
• Tolerance to residual refractive errors: Designed to maintain function with small postoperative refractive variations.
• TECNIS™ platform advantages: Enhanced contrast, optical clarity and rotational stability for toric models.

Indications
The TECNIS Symfony™ OptiBlue™ EDOF IOL (used with the TECNIS SIMPLICITY™ Delivery System) is indicated for primary implantation for visual correction of aphakia in adult patients after cataract extraction. The lens provides extended depth of focus with improved intermediate and near acuity compared with an aspheric monofocal IOL while maintaining comparable distance acuity. Lenses are intended for placement in the capsular bag only. Toric II OptiBlue™ IOLs are indicated for correction of aphakia and reduction of residual refractive astigmatism in adult patients with preoperative corneal astigmatism ≥ 1.0 D.

Warnings

• Not all patients are candidates: patients with recurrent severe anterior or posterior inflammation, active ocular infection, compromised eyes from trauma, uncontrolled glaucoma, corneal endothelial dystrophy, proliferative diabetic retinopathy, or other significant ocular/systemic conditions may be unsuitable.
• Placement: Lens must be placed entirely in the capsular bag; do not place in the ciliary sulcus.
• Contrast sensitivity: This IOL may reduce contrast sensitivity under certain conditions compared to an aspheric monofocal IOL; discuss this possibility with patients prior to implantation.
• Visual phenomena: Some patients may experience halos, glare or starbursts due to elongation of focus; these phenomena can be bothersome and, rarely, may necessitate lens removal.
• Toric considerations: Predicted postoperative astigmatism >1.0 D may make non-toric models unsuitable; toric models require accurate preoperative cylinder and axis assessment.
• Rotation risk: Toric IOL rotation from the intended axis reduces astigmatic correction; misalignment >30° may increase postoperative refractive cylinder and may require early repositioning.
• Single-use devices: IOLs and delivery systems are single-use; do not reuse.
• Do not disassemble, modify or alter the delivery system or its components.

Precautions

• Single-use: Do not resterilize the lens or delivery system.
• Storage and temperature: Do not store in direct sunlight or at temperatures <41°F (5°C) or >95°F (35°C). Recommended implantation temperature ≥63°F (17°C).
• Do not autoclave the delivery system.
• Use balanced salt solution or appropriate ophthalmic viscoelastics with the delivery system; HEALON™ family recommended where applicable.
• Do not use if cartridge is cracked or split prior to implantation.
• Follow hydration and handling instructions to avoid lens damage or sticking; minimum hydration and timing requirements apply.
• Surgeon responsibilities: Provide patients with information on risks and benefits per institutional practice; perform careful preoperative evaluation and accurate keratometry/biometry.
• Refraction caution: Interpret results from autorefractors or wavefront aberrometers that use infrared light with caution; confirm with manifest refraction as appropriate.
• Centration: Careful centration is required; decentration may cause visual disturbances.
• Retinal treatments: Lens optical design may affect certain retinal treatments; consider when planning interventions.

Potential Adverse Effects

• Infection (endophthalmitis)
• Hypopyon
• IOL dislocation, tilt or decentration
• Cystoid macular edema
• Corneal edema
• Pupillary block, iritis
• Retinal detachment or tear
• Elevated intraocular pressure requiring treatment
• Visual symptoms potentially requiring secondary intervention or lens removal

Additional Notes
Rx only. The TECNIS SIMPLICITY™ Delivery System is a preloaded, single-use system designed to fold and assist insertion of the TECNIS Symfony™ OptiBlue™ and TECNIS Symfony™ Toric II OptiBlue™ IOLs. Careful preoperative assessment and accurate toric calculation tools are recommended for toric models to optimize outcomes.

Technical specifications

• Product type: Extended Depth of Focus (EDOF) intraocular lens (IOL)
• Technology: InteliLight™ Technology
• Platform: TECNIS™ platform
• Available configurations: Standard EDOF and Toric II OptiBlue™
• Indication: Primary implantation for visual correction of aphakia in adults after cataract removal; Toric II indicated for reduction of residual refractive astigmatism in eyes with ≥ 1.0 D preoperative corneal astigmatism
• Placement: Capsular bag only
• Clinical performance note: Continuous range of vision with mean visual acuity ~20/32 or better from infinity to <20 inches (study data)
• Model references: DXR00V (Symfony OptiBlue); Toric II models DXW150, DXW225, DXW300, DXW375
• Delivery system: TECNIS SIMPLICITY™ preloaded delivery system (single-use)
• Contraindications/unsuitable candidates: See warnings and precautions for detailed list of ocular and systemic conditions.