- Device
- TECNIS PureSee IOL, Model DEN00V TECNIS PureSee Toric II IOLs, Model DET150, DET225, DET300, DET375
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P980040
- Supplement
- S176
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2026-03-11
- Decision code
- APPR
- Date received
- 2025-07-31
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the TECNIS SIMPLICITY™ Delivery System 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. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the TECNIS PureSee™ IOL provides improved intermediate visual acuity, while maintaining comparable distance visual acuity. The lens is intended for capsular bag placement only. The TECNIS SIMPLICITY™ Delivery System is used to fold and assist in inserting the TECNIS PureSee™ Toric II IOLs, 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. The lenses mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the TECNIS PureSee™ Toric II IOLs provide improved intermediate visual acuity, while maintaining comparable distance visual acuity. The lenses are intended for capsular bag placement only.