When did Clareon Vivity Pro Extended Vision IOLs receive FDA clearance or approval?

Clareon Vivity Pro Extended Vision IOLs (Submission ID: P190018) was fda approved by the U.S. FDA on 2026-10-30 under the PMA pathway with a review duration of 169 days.

Who is the manufacturer or applicant for Clareon Vivity Pro Extended Vision IOLs?

The applicant and sponsor for P190018 is Alcon Laboratories, LLC.

Is P190018 an AI/ML-enabled medical device?

No. This medical device submission is not designated as incorporating AI/ML software algorithms.

FDA Approved Existing Device (Modification) Pathway: PMA

Clareon Vivity Pro Extended Vision IOLs

Applicant: Alcon Laboratories, LLC ALC

Statutory Profile

Legal Standard:

Reasonable assurance of safety and effectiveness (Section 515 FD&C Act)

Product Code:

POE

Review Panel:

Ophthalmic

21 CFR Regulation:

Unspecified

Review Velocity Metrics

Date Received:

2026-05-14

Decision Date:

2026-10-30

Total Review Duration:

169 calendar days (169 days)

Official FDA Research Backlinks

Direct links to primary official records hosted by the U.S. Food and Drug Administration CDRH databases:

FDA Database Webpage (pmn.cfm) Official Decision Summary PDF Product Classification Database Establishment Registration & Listing

Identified Contacts & Correspondents

Amy Ryan

Role: US_AGENT

📞 817-5518663

✉️ dale.schaper@alcon.com

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