AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL)
FDA premarket approval P930014/S136 · decided 2021-06-22
Approval details
- PMA number
- P930014
- Supplement
- S136
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL)
- Generic name
- Extended depth of focus intraocular lens
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2021-03-26
- Decision date
- 2021-06-22
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- POE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval to increase the spherical power range for the AcrySof IQ Vivity Extended Vision Intraocular Lenses (IOLs), AcrySof IQ Vivity Extended Vision Toric IOLs, AcrySof IQ Vivity Extended Vision UV Absorbing IOLs, and AcrySof IQ Vivity Extended Vision UV Absorbing Toric IOLs from 15 D to 25 D to 10 D to 30 D; and to add a higher cylindrical power toric model to the AcrySof IQ Vivity Extended Vision Toric IOLs (Model DFT615) and AcrySof IQ Vivity Extended Vision UV Absorbing Toric IOLs (Model D
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal (K254052) | Alcon Laboratories, Inc. | 2026-02-13 |
| LenSx Laser System (8065000944) (K252682) | Alcon Laboratories, Inc. | 2025-09-24 |
| LenSx Laser System (8065998162) (K243896) | Alcon Laboratories, Inc. | 2025-04-28 |
| Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric (K243909) | Alcon Laboratories, Inc. | 2025-01-13 |
| Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); (K242184) | Alcon Laboratories, Inc. | 2024-12-04 |
| UNITY VCS (8065000296); UNITY CS (8065000297) (K233876) | Alcon Laboratories, Inc. | 2024-06-21 |
| Centurion™ Vision System (Active Sentry™) (8065753057) (K233902) | Alcon Laboratories, Inc. | 2024-01-10 |
| Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal (K233856) | Alcon Laboratories, Inc. | 2023-12-29 |