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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAcrySof™ IQ Vivity™ Extended Vision Intraocular Lens (IOL)
Generic NameExtended depth of focus intraocular lens
ApplicantAlcon Laboratories, Inc.
6201 S. Fwy. Dr.
Fort Worth, TX 76134
PMA NumberP930014
Supplement NumberS136
Date Received03/26/2021
Decision Date06/22/2021
Product Codes MJP POE 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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).
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