Alcon Laboratories, LLC: PMA supplement approved for Clareon Vivity™ Toric Extended Vision UV Absorbing Hydrophobic Intraocular Lens (IOL)

Alcon Laboratories, LLC (Fort Worth, Texas): PMA supplement approved for Clareon Vivity™ Toric Extended Vision UV Absorbing Hydrophobic Intraocular Lens (IOL). Dated 173 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).

Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)

Free preview: all 8 published fields of this record are shown below. Locked: 17 related TX FdaApprovalPulse records and the 4-column CSV export.

FieldValue
SponsorAlcon Laboratories, LLC
ProductClareon Vivity™ Toric Extended Vision UV Absorbing Hydrophobic Intraocular Lens (IOL)
Generic / ingredientintraocular lens
ApprovalPMA supplement (device change)
ApplicationP190018 S046
Decided2026-05-15
Panel / classOphthalmic
Sponsor locationFort Worth, TX
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  • Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
  • Record date: 2026-05-15
  • Data refreshed: 2026-11-04
  • Refunds on request within 14 days

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LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT

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Peer benchmark and outreach value: Alcon Laboratories, LLC and 18 Texas peers

  • Texas FdaApprovalPulse records like this one: 18
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every Texas peer: $3,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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30 / 100 Score

    What is the FdaApprovalPulse record for Alcon Laboratories, LLC in Fort Worth, Texas?

    The FDA approved Clareon Vivity™ Toric Extended Vision UV Absorbing Hydrophobic Intraocular Lens (IOL) (P190018 S046) for Alcon Laboratories, LLC on 2026-05-15: PMA supplement (device change).

    How does Alcon Laboratories, LLC compare to other Texas FdaApprovalPulse records?

    It is 173 days old; check the official source for later updates before acting. Its Score of 30/100 is modest; treat it as background rather than a priority.

    Alcon Laboratories, LLC vs. top 3 peers

    OrganizationLocationRecord date
    Alcon Laboratories, LLCFort Worth, TX2026-05-15
    Instylla, Inc.Bedford, MA2026-10-23
    Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)Tucson, AZ2026-10-23
    Cerenovus, Inc.Miami, FL2026-10-23

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    ✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days

    From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.

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