# K121555: Centurion Vision System

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Laboratories, Inc.
- Decided: Dec 21, 2012 after 210 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K933880 (1994). 58 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 65 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 2.
- K101285: Constellation Vision System, Alcon Manufacturing, Ltd. (2010) Summary page 1.
- K093305: Enhanced Ultra Vit Probe, Alcon Research, 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.
- K082473: Bausch & Lomb Stellaris Microsurgical System, Bausch & Lomb, Inc. (2009) Summary page 1.
- K063583: Alcon Vision System, Alcon (2008) Summary page 1.
- K060366: The Amo Ophthalmic Surgical System, Advanced Medical Optics, Inc. (2006) Summary page 1.
- K911808: Gemini Ophthalmic Surgery System, Alcon Laboratories (1991) Summary page 1.

## Most influential descendants
- K161794: CENTURION Vision System (Active SentryTM) (2017), 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
- K233902: Centurion™ Vision System (Active Sentry™) (8065753057) (2024), 0 descendants of its own
- K193376: Visalis V500, Visalis S500 (2020), 0 descendants of its own

## Recalls of this device
- Jun 28, 2023 · Class II · Z-2407-2023: Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
- Jun 28, 2023 · Class II · Z-2410-2023: Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
- May 24, 2016 · Class II · Z-2081-2016: The grounding pin within the Power Entry Switch on certain systems was susceptible to detachment when the AC power cable is removed.
- Apr 28, 2016 · Class II · Z-1940-2016: Alcon is conducting this Voluntary Medical Device Removal for specific lots of its CENTURION FMS packs due to the possible presence of a molding irregularity found within the aspiration luer which may

## Indications for use
The CENTURION Vision 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 intraocular lens injection. The AutoSert IOL Injector Handpiece is intended to deliver qualified ACRYSOF intraocular lenses into the eye following cataract removal. The AutoSert IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert IOL Injector Handpiece is indicated for use with ACRYSOF lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, 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/K121555
Methodology: https://510kreport.com/methodology