# K112425: Infiniti Vision System Evergreen II Autosert Iol Injector Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Manufacturing, Ltd.
- Decided: Nov 21, 2011 after 90 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K844373 (1985). 28 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021566: Infiniti, Alcon Laboratories, Inc. (2002) Summary page 1.
- K082845: Infiniti Vision System with Ozil IP, Alcon Research, Ltd. (2009) Summary page 1.
- K091777: Alcon Ultrachopper, Alcon Research, Ltd. (2009) Summary page 1.
- K093210: Aqualase Capsule Wash Tip, Alcon Manufacturing, Ltd. (2010) Summary page 1.
- K063155: Monarch Iii Iol Delivery System, Alcon Manufacturing, Ltd. (2007) Summary page 1.

## Most influential descendants
- K121555: Centurion Vision System (2012), 6 descendants of its own
- K161794: CENTURION Vision System (Active SentryTM) (2017), 3 descendants of its own
- K120912: Infiniti (R) Vision System (2012), 3 descendants of its own
- K141065: Constellation Vision System (2014), 2 descendants of its own
- K233876: Unity VCS (8065000296); Unity CS (8065000297) (2024), 0 descendants of its own

## Indications for use
The Infiniti® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of 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 following system modalities additionally support the described indications: - Ultrasound with UltraChopper Tip achieves the functionality of cataract separation. - AquaLase achieves the functionality for removal of residual cortical material and lens epithelial cells - The AutoSert™ IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert™ is indicated for use with ACRYSOF lenses SN60WF and SN6AD1, 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/K112425
Methodology: https://510kreport.com/methodology