Johnson & Johnson has received FDA approval for the TECNIS PureSee intraocular lens (IOL), designed as an extended-depth-of-focus (EDOF) lens for use in cataract surgery.
Where to begin?
We’ll take a look at the TECNIS platform this lens is based on.
What to know: TECNIS is the core IOL technology incorporated into J&J’s cataract lens portfolio, encompassing:
- Advanced aspheric optics for reduced spherical aberration and improved image quality
- Consistent haptic design for centration and rotational stability in the capsular bag
- Hydrophobic acrylic lens material for long-term stability in the eye
- Optics optimized for contrast sensitivity (particularly in low-light conditions)
How many lenses are included in the TECNIS portfolio?
Quite a few, including both monofocal and presbyopia-correcting (PC) premium IOLs—see here.
Now to this latest addition.
The TECNIS PureSee IOL’s official indication: For primary implantation for the visual correction of aphakia in adult patients (ages 22+) with less than 1 diopter (D) of pre-existing corneal astigmatism in whom a cataractous lens has been removed.
- It’s also intended for capsular bag placement only.
Important to note: The TECNIS PureSee is reported to be the first and only FDA-approved EDOF IOL with no warning on loss of contrast sensitivity (a critical component of visual quality).
And how does it compare to aspheric monofocal IOLs?
The lens offers improved intermediate visual acuity (VA) while also maintaining comparable distance VA and low levels of visual symptoms—with the added bonus of EDOF (to mitigate those presbyopia effects).
- Specifically, clinical evaluations found no clinically meaningful differences (≤0.3 log units) between the lenses’ contrast sensitivities.
So how does TECNIS PureSee target this patient base?
The lens can be used during cataract surgery to address both: cataract-related vision loss and the effects of presbyopia.
- How: By providing EDOF to enable “excellent distance and intermediate vision, with some near vision,” per J&J.
Based on clinical data: A reported 97% of patients experienced no “very bothersome visual disturbances” and had a reduced reliance on glasses following cataract surgery.
Let’s talk the basics of the lens implantation process.
As with other TECNIS IOLs, the PureSee is implanted via the TECNIS Simplicity Delivery System.
What this is: A preloaded, fully disposable, screw-style injector that folds and inserts TECNIS IOLs into the capsular bag during cataract surgery via a flexible and simple three-step process.
- Its advantages: Prevents manual loading errors, streamlines lens delivery, and protects against contamination (see here for specs and a more detailed description).
Any warnings or precautions to be aware of?
But of course. All 11 warnings can be found here (and 23 precautions here).
A few notes:
- Only the TECNIS Toric IOL Calculator was used as a method for selecting cylinder power and the appropriate axis of implantation during the lens’ investigational device exemption (IDE) study
- As such, “accurate keratometry and biometry (plus the calculator) are recommended to achieve optimal visual outcomes for the TECNIS PureSee Toric II IOLs.”
- For contact lens wearers, recent lens usage could impact a patient’s refraction; as such, surgeons should establish corneal stability without the lenses prior to determining IOL power.
- The lens’ safety and effectiveness was not confirmed among pregnant women, patients under the age of 22, or those with certain preexisting ocular conditions and intraoperative complications (see here and here, respectively).
- Surgeons are advised to practice careful evaluation and sound clinical judgement before implanting a lens in patients with one or more of these conditions.
Along those lines, what potential complications might arise following implantation?
Just those generally associated with cataract surgery. Check them out.
And now to the big question: When will the IOL be commercially available?
That’s currently to be determined—J&J only shared plans for the lens to launch in the U.S. “later this year.”
Stay tuned for a more definitive timeframe ...