# K191650: LEGION System

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Research, LLC
- Decided: Nov 1, 2019 after 134 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K933880 (1994). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161794: CENTURION Vision System (Active SentryTM), Alcon Research, Ltd. (2017) Summary page 4.

## Recalls of this device
- Jun 28, 2023 · Class II · Z-2409-2023: Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

## Indications for use
The Legion™ System is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The AutoSert™ IOL Injector Handpiece is intended to deliver qualified AcrySof™ intraocular lenses into the eye following cataract removal. The AutoSert™ JOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert™ IOL Injector Handpiece is indicated for use with AcrySof™ lenses SN6OWF, SN6AD1, SN6AT3 through SN6ATY, as well as approved AcrySof™ lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

Source page: https://510kreport.com/device/K191650
Methodology: https://510kreport.com/methodology