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FDA premarket approval · Johnson & Johnson · Ophthalmology

TECNIS PureSee IOL

An extended-depth-of-focus IOL with contrast comparable to a monofocal.

CompareJohnson & Johnson press release
Approved · PMA

TECNIS PureSee IOL

Johnson & Johnson · Ophthalmology · First EDOF IOL, no contrast-sensitivity warning

Type
Implant
FDA route
Premarket approval (PMA)
Used by
Cataract surgeons
Bottom line for your practice
70s read

Cataract patients have an EDOF lens option that, per its indications, improves intermediate visual acuity compared with an aspheric monofocal IOL while keeping distance acuity comparable, and whose labeling carries no warning on loss of contrast sensitivity. The company says it will be available in the U.S. later this year.

What it is
A purely refractive extended depth of focus (EDOF) intraocular lens implanted in the capsular bag during cataract surgery. It corrects aphakia after cataract removal and mitigates the effects of presbyopia by extending depth of focus.
Indicated for
Adults with less than 1 diopter of pre-existing corneal astigmatism in whom a cataractous lens has been removed, for primary implantation to correct aphakia; the Toric II models are for adults with 1 diopter or more of preoperative corneal astigmatism.
What changes
Compared with an aspheric monofocal IOL, the lens provides improved intermediate visual acuity with comparable distance visual acuity, and the company reports contrast sensitivity comparable to aspheric monofocal controls (differences of 0.3 log units or less).
Evidence
Design not reportedStudy not named in the releaseThe company reports that 97% of patients reported no very bothersome visual disturbances, and a 1.5-line difference in mean monocular distance-corrected near visual acuity at 6 months compared with TECNIS 1-Piece. Contrast sensitivity showed no clinically meaningful differences (0.3 log units or less) versus aspheric monofocal controls.The source does not describe a clinical study or its design. Common for cleared devices, which can rest on equivalence to a predicate.
Watch for
Safety and effectiveness have not been substantiated in pregnant women, patients under 22, or those with preexisting ocular conditions or intraoperative complications listed in the labeling. Autorefractors may not give optimal postoperative refraction (manual refraction is recommended), the lens is for capsular bag placement only, and toric misalignment greater than 30 degrees may increase postoperative refractive cylinder.
FDA decision
  1. 510(k)Cleared
  2. De NovoGranted
  3. PMAApproved
Premarket approval (PMA). The FDA's most demanding device review, for Class III devices that sustain life or carry the highest risk. It requires valid scientific evidence of safety and effectiveness, usually clinical studies, which are not always randomized.

Clinical summary

A purely refractive extended-depth-of-focus intraocular lens for primary implantation after cataract removal in adults with less than 1 diopter of corneal astigmatism. Contrast sensitivity was comparable to an aspheric monofocal IOL, and 97% of patients reported no very bothersome halos or glare. Labeling excludes several ocular comorbidities, including uncontrolled glaucoma, macular disease and diabetic retinopathy.

From the source 14

Johnson & Johnson press release

The Johnson & Johnson press release's own words, quoted exactly. Each line is what a claim on this page was checked against.

  1. Johnson & Johnson announced U.S. Food and Drug Administration (FDA) approval of TECNIS PureSee IOL, an extended depth of focus (EDOF) intraocular lens (IOL) intended for use in cataract surgery.

    Backs · FDA approval (recorded as PMA)

  2. TECNIS PureSee IOL delivers clarity of vision for patients, with 97% of them reporting no very bothersome visual disturbances.

    Backs · 97% no very bothersome visual disturbances

  3. TECNIS PureSee IOL is the first and only U.S. FDA‑approved extended depth of focus (EDOF) IOL with no warning on loss of contrast sensitivity.

    Backs · First claim

View all 14 lines

  1. In clinical evaluation, TECNIS PureSee IOL demonstrated contrast sensitivity comparable to an aspheric monofocal intraocular lens, with no clinically meaningful differences (≤0.3 log units) versus aspheric monofocal controls across pupil sizes, while maintaining distance visual acuity and low levels of visual symptoms.

    Backs · Contrast sensitivity, 0.3 log units

  2. TECNIS PureSee IOL achieved a 1.5-line difference in mean monocular distance-corrected near VA at 6 months compared to TECNIS 1-Piece.

    Backs · 1.5-line difference at 6 months

  3. is used to fold and assist in inserting the TECNIS PureSee™ IOL, which is indicated for primary implantation for the visual correction of aphakia in adult patients with less than 1 diopter of pre-existing corneal astigmatism in whom a cataractous lens has been removed.

    Backs · Indication: adults, less than 1 diopter astigmatism

  4. which are indicated for primary implantation for the visual correction of aphakia and for reduction of refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed.

    Backs · Toric II: 1 diopter or more

  5. Compared to an aspheric monofocal IOL, the TECNIS PureSee™ IOL provides improved intermediate visual acuity, while maintaining comparable distance visual acuity.

    Backs · Comparison with aspheric monofocal IOL

  6. The TECNIS portfolio includes TECNIS PureSee IOL, a purely refractive EDOF IOL;

    Backs · Purely refractive EDOF

  7. The lens is intended for capsular bag placement only.

    Backs · Capsular bag only

  8. The safety and effectiveness of the TECNIS PureSee™ IOLs have not been substantiated in pregnant women, patients under the age of 22 or those with preexisting ocular conditions and intraoperative complications, including those specified in the Warnings and Precautions.

    Backs · Under age 22 not substantiated

  9. Misalignment greater than 30° may increase postoperative refractive cylinder.

    Backs · Misalignment greater than 30 degrees

  10. Autorefractors may not provide optimal postoperative refraction of patients with the IOL. Manual refraction with maximum plus technique is strongly recommended.

    Backs · Autorefractors

  11. TECNIS PureSee IOL will be available for patients in the U.S. later this year.

    Backs · U.S. availability

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