510(k) · Cleared
Recalled · Class II · 2023Centurion Vision System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories, Inc. · HQC Unit, Phacofragmentation
Cleared on Dec 21, 2012 as substantially equivalent to K112425 (Alcon Manufacturing, Ltd., 2011) and 8 other predicates after a 210-day review. Its family tree reaches back 7 generations to 1994. 6 later devices descend from it. It has been recalled 4 times.
- Decided
- Dec 21, 2012
- Review
- 210 days
- Class
- Class II
- Product code
- HQC
- Recalls
- 4
- Predicates
- 9
Its longest line of descent runs back 7 generations to K933880 (1994). 58 ancestors in all, the oldest K842458 (1984). 6 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 6 generations backK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
- 5 generations backK964074 Diolite 532Iriderm Div. · 1997
- 4 generations backK982031 Oculight GL with the Dermatology HandpieceIridex Corp · 1998
- 3 generations backK031665 Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003
- 2 generations backK062624 Next Generation LaserAlcon Laboratories · 2007
- 1 generation backK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- This deviceK121555 Centurion Vision SystemAlcon Laboratories, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK161794 CENTURION Vision System (Active SentryTM)Alcon Research, Ltd. · 2017
- Descendant · cites it directly · 2 of its ownK141065 Constellation Vision SystemAlcon Research, Ltd. · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK233876 Unity VCS (8065000296); Unity CS (8065000297)Alcon Laboratories, Inc. · 2024 · Recalled
- Descendant · 2 generations on · 0 of its ownK233902 Centurion™ Vision System (Active Sentry™) (8065753057)Alcon Laboratories, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK193376 Visalis V500, Visalis S500Carl Zeiss Meditec, AG · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K161794CENTURION Vision System (Active SentryTM)Alcon Research, Ltd. · 2017 · cites it directly3descendants
- K141065Constellation Vision SystemAlcon Research, Ltd. · 2014 · cites it directly2descendants
- K233876Unity VCS (8065000296); Unity CS (8065000297)Alcon Laboratories, Inc. · 2024 · 2 generations on0descendants
- K233902Centurion™ Vision System (Active Sentry™) (8065753057)Alcon Laboratories, Inc. · 2024 · 2 generations on0descendants
- K193376Visalis V500, Visalis S500Carl Zeiss Meditec, AG · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K933880 | SL Series Surgical Laser Systems | Laserscope | 1994 | — |
| −6 | K954905 | CB Diode/532 Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −5 | K964074 | Diolite 532 | Iriderm Div. | 1997 | — |
| −4 | K982031 | Oculight GL with the Dermatology Handpiece | Iridex Corp | 1998 | — |
| −3 | K031665 | Iris Medical Oculight GL/GLX Laser Systems | Iridex Corp | 2003 | — |
| −2 | K062624 | Next Generation Laser | Alcon Laboratories | 2007 | — |
| −1 | K101285 | Constellation Vision System | Alcon Manufacturing, Ltd. | 2010 | 4 |
| 0 (this device) | K121555 | Centurion Vision System | Alcon Laboratories, Inc. | 2012 | — |
| +1 | K161794 | CENTURION Vision System (Active SentryTM) | Alcon Research, Ltd. | 2017 | — |
| +1 | K141065 | Constellation Vision System | Alcon Research, Ltd. | 2014 | 6 |
| +2 | K233876 | Unity VCS (8065000296); Unity CS (8065000297) | Alcon Laboratories, Inc. | 2024 | 2 |
| +2 | K233902 | Centurion™ Vision System (Active Sentry™) (8065753057) | Alcon Laboratories, Inc. | 2024 | — |
| +2 | K193376 | Visalis V500, Visalis S500 | Carl Zeiss Meditec, AG | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 5 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HQC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HQC device
- #1 K261264 Stellaris Elite™ vision enhancement system…score 13.4 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K112425 | Infiniti Vision System Evergreen II Autosert Iol Injector HandpieceSummary page 2…21, 2012 5.2 Device Description The CENTURION® Vision System is a phacofragmentation system similar to the Alcon INFINITI® Vision System (Evergreen 11- K112425). It is designed for emulsification, separation, irrigation and aspiration of cataracts, residual cortical material… | 2011 |
| * | K101285 | Constellation Vision SystemSummary page 1…7 Alcon INFINITIO Vision System Ki 12425 11/21/2011 (Evergreen 11) CONSTIELLATIQNO' Vision K101285 11/12/2010 System Alcon Enhanced UltraVit Probe K093305 04/02/2010… | 2010 |
| * | K093305 | Enhanced Ultra Vit ProbeSummary page 1…(Evergreen 11) CONSTIELLATIQNO' Vision K101285 11/12/2010 System Alcon Enhanced UltraVit Probe K093305 04/02/2010 Alcon UltraChopperE Tip K091777 10/20/2009 INFlNlTlu w/OZ… | 2010 |
| * | K091777 | Alcon UltrachopperSummary page 1…11/12/2010 System Alcon Enhanced UltraVit Probe K093305 04/02/2010 Alcon UltraChopperE Tip K091777 10/20/2009 INFlNlTlu w/OZiIv IP K082845 02/12/2009 Bausch & Lomb… | 2009 |
| * | K082845 | Infiniti Vision System with Ozil IPSummary page 1…K093305 04/02/2010 Alcon UltraChopperE Tip K091777 10/20/2009 INFlNlTlu w/OZiIv IP K082845 02/12/2009 Bausch & Lomb Microsurgical K082473 01/05/2009 System (Stell… | 2009 |
| * | K082473 | Bausch & Lomb Stellaris Microsurgical SystemSummary page 1…K091777 10/20/2009 INFlNlTlu w/OZiIv IP K082845 02/12/2009 Bausch & Lomb Microsurgical K082473 01/05/2009 System (Stellaris) _________ Alcon Vision System… | 2009 |
| * | K063583 | Alcon Vision SystemSummary page 1…urgical K082473 01/05/2009 System (Stellaris) _________ Alcon Vision System K063583 05/09/2008 AMO Ophthalmic Surgical System K060366 04/07/2006 (Whitestar Si… | 2008 |
| * | K060366 | The Amo Ophthalmic Surgical SystemSummary page 1…_________ Alcon Vision System K063583 05/09/2008 AMO Ophthalmic Surgical System K060366 04/07/2006 (Whitestar Signature) _________ Gemini Ophthalmic Surgical… | 2006 |
| * | K911808 | Gemini Ophthalmic Surgery SystemSummary page 1…l System K060366 04/07/2006 (Whitestar Signature) _________ Gemini Ophthalmic Surgical K(911808 06/25/1 991 System (ACCURUSO) ______ _______ Alcon La… | 1991 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 28, 2023 | Class II | Z-2407-2023 | Process control | 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 | Process control | 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 | Nonconforming Material/Component | 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 | Process control | 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 result in a reduction of vacuum… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 16 of the 58 ancestors have a recall of any class.
- Of its descendants, K161794 (Alcon Research, Ltd., 2017) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K112425.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HQC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQC
1,799in 2025
MAUDE reports naming product code HQC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 341 |
| 2008 | 4 | 162 | 1 | 444 |
| 2009 | 5 | 131 | 1 | 540 |
| 2010 | 3 | 142 | 22 | 2,431 |
| 2011 | 5 | 129 | 4 | 1,802 |
| 2012 | 5 | 125 | 1 | 2,277 |
| 2013 | 0 | — | 0 | 2,772 |
| 2014 | 4 | 135 | 1 | 2,740 |
| 2015 | 3 | 124 | 0 | 3,355 |
| 2016 | 1 | — | 0 | 3,374 |
| 2017 | 3 | 214 | 0 | 2,781 |
| 2018 | 0 | — | 2 | 2,416 |
| 2019 | 4 | 126 | 0 | 2,287 |
| 2020 | 4 | 227 | 0 | 1,217 |
| 2021 | 1 | — | 0 | 1,673 |
| 2022 | 4 | 245 | 5 | 1,907 |
| 2023 | 1 | — | 1 | 1,799 |
| 2024 | 5 | 197 | 0 | 2,120 |
| 2025 | 3 | 267 | 1 | 1,799 |
| 2026 | 3 | 115 | 0 | — |
What is it indicated for?
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…
Read the full statement (108 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121555: Centurion Vision System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121555
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026