- Device
- AcrySof™ IQ Vivity™ Extended Vision Intraocular Lens (IOL)
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P930014
- Supplement
- S136
- Product code
- POE
- Generic name
- Extended depth of focus intraocular lens
- Decision date
- 2021-06-22
- Decision code
- APPR
- Date received
- 2021-03-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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 DAT615).