# P190018: Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens

- Pathway: PMA
- Applicant: Alcon Laboratories, LLC
- Decided: Jan 7, 2020 after 180 days
- Product code: HQL (Intraocular Lens)
- Device class: 3
- Regulation: 21 CFR 886.3600
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- May 11, 2022 · Class II · Z-1269-2022: Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.

Source page: https://510kreport.com/device/P190018
Methodology: https://510kreport.com/methodology