FDA Approves TECNIS PureSee IOL for Cataract Surgery

First FDA-approved extended depth of focus (EDOF) IOL maintaining contrast sensitivity comparable to an aspheric monofocal IOL

March 23, 2026
2 min

The Ophthalmologist

Overview

The FDA has approved the TECNIS PureSee intraocular lens (IOL), an extended depth of focus (EDOF) lens designed for cataract surgery. This lens aims to improve visual performance by addressing both cataract-related vision loss and presbyopia, while maintaining contrast sensitivity.

Background

Cataract surgery is a common procedure that can significantly enhance the quality of life for patients suffering from vision impairment. With an estimated 94 million individuals aged 50 and over experiencing moderate-to-severe distance vision issues, the introduction of advanced IOLs like the TECNIS PureSee is crucial. This lens not only addresses cataracts but also mitigates presbyopia, offering a broader range of vision.

Data Highlights

Study	Findings
Pivotal Trial	All primary effectiveness endpoints met; PureSee improved intermediate visual acuity while maintaining distance acuity.
Contrast Sensitivity	Differences versus monofocal IOLs were ≤0.3 log units across spatial frequencies.
Adverse Events	No serious device-related adverse events; ocular serious events ≤4.8%.

Key Findings

TECNIS PureSee IOL is the first FDA-approved EDOF IOL with no warning on loss of contrast sensitivity.
97% of patients reported no very bothersome visual disturbances post-surgery.
The lens provides excellent distance and intermediate vision, with some near vision capabilities.
It uses a purely refractive OptiCurve posterior optic to extend depth of focus.
FDA approval was based on a multicenter, randomized, bilateral, masked trial.

Clinical Implications

The introduction of the TECNIS PureSee IOL offers a new option for cataract patients, particularly those with presbyopia. Clinicians should consider this lens for patients seeking to reduce their dependence on glasses while maintaining visual clarity.

Conclusion

The FDA approval of the TECNIS PureSee IOL represents a significant advancement in cataract surgery, providing patients with enhanced visual performance and quality of life.