Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceClareon Vivity Pro Extended Vision IOLs
Generic NameExtended depth of focus intraocular lens
ApplicantAlcon Laboratories, LLC
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP190018
Supplement NumberS050
Date Received05/14/2026
Decision Date10/30/2026
Product Codes MJP POE 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for the Clareon Vivity Pro Extended Vision IOLs, Clareon Vivity Pro Extended Vision Toric IOLs, Clareon Vivity Pro Extended Vision UV Absorbing IOL, Clareon Vivity Pro Extended Vision Toric UV Absorbing IOLs, Clareon Vivity Pro Extended Vision IOL with the AutonoMe Pre-loaded Delivery System, Clareon Vivity Pro Extended Vision Toric IOLs with the AutonoMe Pre-loaded Delivery System, Clareon Vivity Pro Extended Vision UV Absorbing IOL with the AutonoMe Pre-loaded Delivery System, and Clareon Vivity Pro Extended Vision Toric UV Absorbing IOLs with the AutonoMe Pre-loaded Delivery System
-
-