What TECNIS Synergy is
Synergy is a diffractive presbyopia-correcting IOL designed to cover distance, intermediate and near. In the trial, that meant 4 m, 66 cm and 40 cm—road, computer and reading distances rather than three abstract labels.
The FDA approved it on April 28, 2021 under PMA P980040/S124. The main model was ZFR00V, with related delivery-system and toric versions. Technical phrases such as “continuous EDOF profile” describe the design claim; the visual and questionnaire results below show what the implanted patients actually achieved.
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/S124, Figure 1
Where the data on this page comes from
FDA Summary of Safety and Effectiveness Data (SSED) — PMA P980040/S124 (PDF)
As with our other model reviews, every figure below comes from the lens's FDA Summary of Safety and Effectiveness Data (SSED) — the public document FDA publishes alongside approval, drawn from the same pivotal clinical trial the manufacturer used to obtain clearance (PMA P980040/S124, approved April 28, 2021: 297 enrolled patients, 272 implanted — 135 Synergy, 137 with a monofocal control lens — across 15 U.S. sites, followed to 6 months). Every number is cited to its table in that document so it can be checked directly.
One gap is worth flagging upfront: the SSED presents its defocus curve and contrast-sensitivity results only as graphs, not as data tables — a common practice in these documents. That means we can report the narrative conclusions FDA and the manufacturer drew from those graphs, but we can't reproduce exact per-diopter or per-spatial-frequency numbers the way we can for the visual-acuity and questionnaire tables, which are published as text. Where a claim below relies on a graph rather than a table, we say so explicitly rather than estimating numbers we can't verify.
Visual acuity by distance
Unlike some other lenses in this category, Synergy's pivotal trial reported distance-corrected visual acuity at all three functional distances — distance, intermediate, and near — which lets us show a complete picture.
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/S124, Tables 18, 22 and 25
The pattern here is different from a monofocal lens or from lenses that only extend intermediate range: Synergy's advantage over the control widens as the task moves closer, and near vision — traditionally the weakest point for EDOF-style designs — shows the largest gap in this dataset. Distance vision was effectively equivalent between the two groups, which is the expected trade-off baseline for a lens spreading light across additional focal points.
For daily meaning, the group average was about 20/23 at 66 cm versus 20/43 with the control, and about 20/25 at 40 cm versus 20/67. The lens did what its full-range design was supposed to do in this trial.
Depth of focus and contrast sensitivity — what the graphs show
The SSED reports mean monocular, distance-corrected visual acuity of 0.2 logMAR or better (≤0.2) from 0.0 D to −2.5 D of defocus, sustained beyond −3.0 D at 6 months (Figure 10, pp. 42–44). Distance correction stays in place while added lenses simulate different viewing distances. This describes the lens's range under those test conditions, not guaranteed unaided vision for every patient. The SSED gives no numeric value for every defocus step, so we have not reconstructed a curve.
On contrast sensitivity, the SSED's narrative conclusion is that sensitivity was "generally lower for the Synergy group than the control group... especially under extremely high glare conditions," while stating this difference was "not found to be associated with clinically significant impact." Again, this comes from graphs (contrast-sensitivity figures around pp. 28–31 of the SSED) rather than a published numeric table, so we're summarizing the document's own stated conclusion rather than presenting exact figures we can't independently verify.
Spectacle independence
% of patients (Patient Reported Spectacle Independence Questionnaire).
Source: FDA SSED, PMA P980040/S124, Figure 13
This is the largest and most consistent gap in the entire dataset, and it reflects the lens's core design goal — reducing glasses dependence across all distances, not just one. It's a patient-reported questionnaire result, not an objective acuity measurement, so it reflects subjective experience rather than a clinical test.
Visual disturbances (halos, glare, starbursts)
% of patients who mentioned the symptom without being prompted by a specific question.
Source: FDA SSED, PMA P980040/S124, Table 16
This is the clearest limitation in the same dataset that showed strong spectacle independence. Halos were reported by roughly 1 in 5 Synergy patients versus roughly 1 in 25 control patients. On the follow-up "how bothered are you" questionnaire (Table 17), 3.8% of Synergy patients rated halos as causing extreme bother and 5.3% rated starbursts as extreme, versus 0% of control patients for both. Those percentages are small, but the difference from this study's own control is real.
Possible limitations, based on this data
- Halos, night glare, and starbursts were reported substantially more often than with the monofocal control lens (roughly 6× as often for halos), and a small but non-zero share of patients (up to 5.3%) rated a symptom as extremely bothersome.
- Contrast sensitivity was reduced under glare conditions compared with the control lens; the SSED describes this as not clinically significant, though this conclusion is stated narratively rather than shown in a published data table.
- The defocus curve and contrast-sensitivity results exist only as graphs in the SSED, not as numeric tables — so exact per-diopter or per-spatial-frequency figures can't be independently verified from the published document.
- This is one 6-month industry-sponsored registration trial with 135 Synergy patients — a valid basis for FDA approval, but shorter and smaller than the body of evidence that exists for older, more established lens designs.
- The trial average cannot predict one eye. Residual prescription, astigmatism, ocular surface, cornea, retina, optic nerve and IOL position can all change the result and should be checked if vision or symptoms are disappointing.
Who should discuss this lens
Synergy gives a clear reason to consider it: broad near-to-far acuity and high reported spectacle independence in its pivotal study. It also gives a clear reason for caution when night driving is non-negotiable: halos, night glare and starbursts were reported more often than with the monofocal control. A preoperative personality label cannot predict who will be bothered. Ask whether your eye is medically suitable, then compare that measured near benefit with the measured symptom risk.
How it compares
Synergy sits within the full-range / extended-vision category — lenses aiming to cover distance, intermediate, and near from a single implant, generally through diffractive designs that split light across multiple focal points. For the category-level trade-offs (versus standard monofocal, enhanced monofocal, and non-diffractive EDOF lenses), see Full Range / Trifocal / Multifocal. For a broader look at why some patients report dissatisfaction with presbyopia-correcting lenses in this category generally, see Why Do Some Presbyopia-Correcting IOL Patients Report Dissatisfaction?
Questions for your surgeon
- How important is unaided 40 cm reading for me compared with night driving?
- What do you count as a tolerable halo, and how many of your patients remain meaningfully bothered?
- Does my ocular surface, cornea, retina or optic nerve change the recommendation?
- Which exact lower-halo alternative would you compare, and what difference in near vision should I expect?
A note on how manufacturers present this same data
As with other lenses in this category, it's worth understanding how this same underlying trial tends to be repackaged for sales materials. A common pattern is to lead with the most favorable single metric — such as the spectacle-independence figure shown above, which is genuinely strong — while presenting visual-disturbance data, when shown at all, using different comparison groups, older competitor products, or bench-optics measurements rather than the same patient-reported clinical outcomes shown side-by-side here. Materials distributed to prescribers frequently draw on internal "Data on File" studies that aren't independently published or peer-reviewed, and are often explicitly restricted to healthcare-professional audiences rather than intended for patients to read directly. We've used the public FDA record instead, and presented the favorable and unfavorable results from the same trial together, because a patient weighing this trade-off needs both halves of the picture at once.
If a sales slide uses MTF or a model-eye comparison, first read how IOLs are tested in the lab before treating that graph as a patient outcome.
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/S124 and cited by table or figure number so you can verify it yourself; where the source document presents a result only as a graph rather than a data table, we've said so rather than estimating numbers we can't confirm. 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.