What TECNIS PureSee is
TECNIS PureSee is a non-diffractive, fully refractive intraocular lens from Johnson & Johnson Surgical Vision. It was approved by the FDA on March 11, 2026 under PMA P980040, supplement S176, as a non-toric model (DEN00V) and a toric line (DET150 / DET225 / DET300 / DET375, for 1.50–3.75 D of corneal astigmatism). It sits in the same general design family as TECNIS Eyhance — a continuous refractive change in curvature rather than diffractive rings — aiming to extend usable range without the halo/glare trade-offs typical of diffractive multifocal and trifocal lenses.
What it looks like
The image below is reproduced from the lens's own FDA regulatory filing, not manufacturer marketing artwork, so what is shown is exactly what the FDA reviewed and approved.
Source: FDA SSED, PMA P980040/S176, Figure 1
Where the data on this page comes from
Every figure below is drawn from the lens's FDA Summary of Safety and Effectiveness Data (SSED) — the public regulatory document FDA publishes when it approves a device, based on the clinical study the manufacturer submitted to obtain approval (PMA P980040/S176, approved March 11, 2026). This is a deliberate choice: it's the same underlying trial the manufacturer's own marketing draws from, but published in full by a regulator rather than selected and formatted for a sales presentation. We link the exact table each number comes from so you can check it yourself.
Two limitations are worth stating upfront, in the same spirit of transparency. First, the version of the SSED available at the time of writing did not include accessible near-vision (40 cm) results or the study's spectacle-independence and satisfaction questionnaire outcomes — those tables exist in the source document but weren't retrievable from the pages we could access, so they're left out below rather than filled in from another source. Second, this is a single 6-month registration trial (115 PureSee patients vs. 113 patients with a monofocal control lens, across 9 U.S. sites) — a solid basis for regulatory approval, but not the same as years of accumulated independent, real-world data.
Visual acuity by distance
The study's primary effectiveness endpoint was intermediate vision at 66 cm, where PureSee showed a statistically significant advantage over the monofocal control lens (p<0.0001). Distance vision was measured as non-inferior to the control, which is the expected and appropriate result for a lens whose selling point is added intermediate range, not sharper distance vision.
Bars show relative acuity — longer bar = sharper vision. Exact logMAR value (lower is better) and Snellen equivalent shown at right.
Source: FDA SSED, PMA P980040/S176, Tables 20, 32 and 35
Note the pattern: distance vision is essentially tied with the control lens, and the PureSee advantage grows the closer the task gets to arm's length — which is exactly the range (66–100 cm) where standard monofocal lenses tend to feel weakest for computer work, dashboards, and similar everyday tasks. Near vision (40 cm, reading distance) was not included above because that data wasn't accessible in the SSED pages available at the time of writing — see the note above.
Contrast sensitivity
Log units — higher is better. Measured in low-light (mesopic) conditions.
Source: FDA SSED, PMA P980040/S176, Table 21
Contrast sensitivity was close to the monofocal control at low and medium spatial frequencies, with a modestly lower reading at the highest frequency tested (12 cpd). The SSED states the difference at every frequency stayed within the study's own success criterion (0.3 log units). Only mesopic (low-light) contrast sensitivity was accessible in the pages we could retrieve — a separate photopic (daytime) table may exist elsewhere in the document but wasn't available to us.
Visual disturbances (halos, glare, starbursts)
% of patients who mentioned the symptom without being prompted by a specific question.
Source: FDA SSED, PMA P980040/S176, Table 22
These are spontaneous reports, not a directed severity questionnaire — meaning patients mentioned these symptoms unprompted rather than being asked to rate them. The SSED specifically notes that none of the PureSee patients described their halos, night glare, or starbursts as severe. On a follow-up "how bothered are you" questionnaire (Table 24), the share of patients "very or extremely bothered" by halos and starbursts was identical between the two groups (2.7% each), though PureSee patients reported somewhat more bother from light sensitivity (6.2% vs. 6.3% is effectively tied) and less from glare (2.7% vs. 5.5%) — a mixed picture rather than a one-directional trend.
Possible limitations, based on this data
- Near vision (40 cm, reading distance) results were not accessible in this SSED at the time of writing — patients considering this lens should ask their surgeon directly what near-vision outcome to expect, since the design's own category (non-diffractive EDOF) does not typically target full spectacle-free near vision.
- Night glare and starbursts were reported more often than with the monofocal control lens (4.4% vs. 1.8%, and 5.3% vs. 0.9% respectively), though absolute rates were low and none were rated severe.
- Contrast sensitivity at the highest spatial frequency tested (12 cpd) was modestly lower than the control lens.
- This is one 6-month industry-sponsored registration trial with 115 PureSee patients — a valid basis for FDA approval, but a smaller and shorter dataset than exists for older, more established lens designs.
- Spectacle-independence and overall satisfaction survey results, though collected as part of the study, were not accessible in the SSED pages available to us and are not represented above.
Who this lens may suit
Based on what this data shows, PureSee follows the same general pattern as other non-diffractive EDOF and enhanced monofocal lenses: patients who want a meaningful boost to intermediate vision (computer work, dashboards, cooking) without the added halo/glare burden that diffractive multifocal and trifocal lenses can bring, and who are comfortable continuing to use reading glasses for sustained close work. Whether that trade-off fits your own priorities, eye health, and lifestyle is a conversation for your surgeon, based on your own measurements — not something a general article can determine for you.
How it compares
PureSee is part of the broader non-diffractive EDOF category — lenses that stretch a single focal point through refractive curvature changes rather than splitting light with diffractive rings. For the category-level trade-offs (versus standard monofocal, diffractive EDOF, and full-range/trifocal lenses), see EDOF (Extended Depth of Focus) and Non-Diffractive EDOF Lenses: A Newer Approach to Extended Range, which looks at how this design approach compares with earlier non-diffractive designs like Eyhance.
A note on how manufacturers present this same data
It's worth understanding how this kind of clinical data is typically packaged for marketing purposes, since it explains why an independent, source-cited summary reads differently. Manufacturer sales materials for lenses in this category commonly headline a single favorable comparison — for example, a bench-optics measurement (like modulation transfer function, a lab measurement of image contrast at a given pupil size) framed under a headline claiming broader "superior" real-world performance against a list of competitor lenses, even though the underlying test is optical-bench data rather than a patient-reported clinical outcome. The competitor lenses shown in any single slide are also a choice made by the manufacturer, not a complete or independently curated field. Much of this material is sourced from internal, unpublished "Data on File" studies rather than the peer-reviewed or FDA-published trials cited throughout this page, and is often explicitly labeled for distribution to healthcare professionals only, rather than for direct patient use — which is one reason we've built this page from the public FDA record instead of reproducing that material here. None of this means the underlying products are ineffective; it means marketing materials are optimized to persuade, while a regulatory filing is optimized to document — and the two are worth reading differently.
Primary source
FDA Summary of Safety and Effectiveness Data, PMA P980040/S176 (March 11, 2026).
A note on this review
This page is educational content, not a clinical trial result and not a personal recommendation. Every figure is sourced directly from the FDA's public SSED for PMA P980040/S176 and cited by table number so you can verify it yourself; where the accessible pages of that document didn't contain a result (near vision, spectacle-independence and satisfaction survey data), we've said so rather than filling the gap from another source. Actual outcomes vary from patient to patient, and the right lens for you can only be determined by a qualified ophthalmic surgeon based on your individual eye measurements and health history.