PMA
P190018: Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens
FDA PMA · Intraocular lens · Alcon Laboratories, LLC
Key facts
| PMA number | P190018 |
|---|---|
| Trade name | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens |
| Generic name | Intraocular lens |
| Applicant | Alcon Laboratories, LLC |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | HQL |
| Approval date | Jan 7, 2020 |
| Docket number | 20M-0108 |
| Notice date | Jan 10, 2020 |
| Establishment registration | 1610287 |
| FEI number | 1610287 |
At a glance
- 10–99 Supplements
- Aug 17, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1,000+ UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: