# K120912: Infiniti (R) Vision System

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Manufacturing, Ltd.
- Decided: Jun 15, 2012 after 81 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: 6 generations back to K844373 (1985). 29 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112425: Infiniti Vision System Evergreen II Autosert Iol Injector Handpiece, Alcon Manufacturing, Ltd. (2011) Summary page 1.
- K093210: Aqualase Capsule Wash Tip, Alcon Manufacturing, Ltd. (2010) Summary page 1.
- K091777: Alcon Ultrachopper, Alcon Research, Ltd. (2009) Summary page 1.
- K082845: Infiniti Vision System with Ozil IP, Alcon Research, Ltd. (2009) Summary page 1.
- K063155: Monarch Iii Iol Delivery System, Alcon Manufacturing, Ltd. (2007) Summary page 1.
- K021566: Infiniti, Alcon Laboratories, Inc. (2002) Summary page 1.

## Most influential descendants
- K141065: Constellation Vision System (2014), 2 descendants of its own
- K233876: Unity VCS (8065000296); Unity CS (8065000297) (2024), 0 descendants of its own
- K193376: Visalis V500, Visalis S500 (2020), 0 descendants of its own

## Recalls of this device
- Oct 30, 2014 · Class II · Z-0506-2015: Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in the aspiration line.

## 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 INTREPID® Autoer® ]IL Injector Handpiece is intended to deliver qualified AcrySoftm 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. - AquaL-ase achieves the functionality for removal of residual cortical material and lens epithelial cells - The INTREPID®D Autoert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The INTREPID® Autoert®' lOL Injector Handpiece is indicated for use with ACRYSOF lenses SNGOWF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySofo 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/K120912
Methodology: https://510kreport.com/methodology