510(k) · Cleared
Recalled · Class II · 2025Constellation Vision System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Research, Ltd. · HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Cleared on Aug 22, 2014 as substantially equivalent to K101285 (Alcon Manufacturing, Ltd., 2010) and 7 other predicates after a 120-day review. Its family tree reaches back 8 generations to 1994. 2 later devices descend from it. It has been recalled 6 times.
- Decided
- Aug 22, 2014
- Review
- 120 days
- Class
- Class II
- Product code
- HQE
- Recalls
- 6
- Predicates
- 8
Its longest line of descent runs back 8 generations to K933880 (1994). 60 ancestors in all, the oldest K842458 (1984). 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 7 generations backK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
- 6 generations backK964074 Diolite 532Iriderm Div. · 1997
- 5 generations backK982031 Oculight GL with the Dermatology HandpieceIridex Corp · 1998
- 4 generations backK031665 Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003
- 3 generations backK062624 Next Generation LaserAlcon Laboratories · 2007
- 2 generations backK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- 1 generation backK121555 Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · Recalled
- This deviceK141065 Constellation Vision SystemAlcon Research, Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK233876 Unity VCS (8065000296); Unity CS (8065000297)Alcon Laboratories, Inc. · 2024 · Recalled
- Descendant · cites it directly · 0 of its ownK193376 Visalis V500, Visalis S500Carl Zeiss Meditec, AG · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K933880 | SL Series Surgical Laser Systems | Laserscope | 1994 | — |
| −7 | K954905 | CB Diode/532 Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −6 | K964074 | Diolite 532 | Iriderm Div. | 1997 | — |
| −5 | K982031 | Oculight GL with the Dermatology Handpiece | Iridex Corp | 1998 | — |
| −4 | K031665 | Iris Medical Oculight GL/GLX Laser Systems | Iridex Corp | 2003 | — |
| −3 | K062624 | Next Generation Laser | Alcon Laboratories | 2007 | — |
| −2 | K101285 | Constellation Vision System | Alcon Manufacturing, Ltd. | 2010 | 4 |
| −1 | K121555 | Centurion Vision System | Alcon Laboratories, Inc. | 2012 | 4 |
| 0 (this device) | K141065 | Constellation Vision System | Alcon Research, Ltd. | 2014 | — |
| +1 | K233876 | Unity VCS (8065000296); Unity CS (8065000297) | Alcon Laboratories, Inc. | 2024 | 2 |
| +1 | 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 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 1 | 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 HQE? 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 HQE device
- #1 K212763 UniVit HE, UniVit UHSscore 4.1 · 2 generations · no Class I recall
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | K101285 | Constellation Vision SystemSummary page 5…redicate Devices: The legally marketed device(s) to which Alcon is claiming substantial equivalence are: 510(k) Number Date Cleared Device K101285 11/12/2010 CONSTELLATION® Vision System K063583 05/09/2008 K121555… | 2010 |
| * | K063583 | Alcon Vision SystemSummary page 5…bstantial equivalence are: 510(k) Number Date Cleared Device K101285 11/12/2010 CONSTELLATION® Vision System K063583 05/09/2008 K121555 12/21/2012 CENTURION® Vision System K120912… | 2008 |
| * | K121555 | Centurion Vision SystemSummary page 5…ber Date Cleared Device K101285 11/12/2010 CONSTELLATION® Vision System K063583 05/09/2008 K121555 12/21/2012 CENTURION® Vision System K120912 06/15/2012 INFINITI® Vision Syste… | 2012 |
| * | K120912 | Infiniti (R) Vision SystemSummary page 5…1/12/2010 CONSTELLATION® Vision System K063583 05/09/2008 K121555 12/21/2012 CENTURION® Vision System K120912 06/15/2012 INFINITI® Vision System 5 510(K) SUMMARY 510(k) Number Date… | 2012 |
| * | K112425 | Infiniti Vision System Evergreen II Autosert Iol Injector HandpieceSummary page 6…K120912 06/15/2012 INFINITI® Vision System 5 510(K) SUMMARY 510(k) Number Date Cleared Device K112425 11/21/2011 K082845 02/12/2009 K021566 07/02/2002 K0… | 2011 |
| * | K082845 | Infiniti Vision System with Ozil IPSummary page 6…INFINITI® Vision System 5 510(K) SUMMARY 510(k) Number Date Cleared Device K112425 11/21/2011 K082845 02/12/2009 K021566 07/02/2002 K091777 10/20/2009 Alco… | 2009 |
| * | K021566 | InfinitiSummary page 6…(K) SUMMARY 510(k) Number Date Cleared Device K112425 11/21/2011 K082845 02/12/2009 K021566 07/02/2002 K091777 10/20/2009 Alcon UltraChopper 5.2 Device Descr… | 2002 |
| * | K091777 | Alcon UltrachopperSummary page 6…Date Cleared Device K112425 11/21/2011 K082845 02/12/2009 K021566 07/02/2002 K091777 10/20/2009 Alcon UltraChopper 5.2 Device Description: The CONSTELLATION® Vision System is d… | 2009 |
What descends from it? (2)
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 |
|---|---|---|---|---|
| Aug 5, 2025 | Class II | Z-0304-2026 | Process control | Due to incomplete seals in the pouch which provide the sterile barrier. |
| Aug 5, 2025 | Class II | Z-0305-2026 | Process control | Due to incomplete seals in the pouch which provide the sterile barrier. |
| Apr 28, 2025 | Class II | Z-2108-2025 | Under Investigation by firm | Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of… |
| Apr 28, 2025 | Class II | Z-2109-2025 | Under Investigation by firm | Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of… |
| Aug 18, 2023 | Class II | Z-0099-2024 | Component change control | Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component failure and loss of pressure control for the use of cutters, scissors… |
| Jun 28, 2023 | Class II | Z-2406-2023 | Process control | Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 18 of the 60 ancestors have a recall of any class.
- Of its descendants, K233876 (Alcon Laboratories, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K101285.
How does its category compare?
All HQE devicesHQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HQE
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HQE
Too few HQE 510(k)s in any year since 2007 to give a median.
Recalls per year · HQE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQE
339in 2025
MAUDE reports naming product code HQE, 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 | — | 2 | 300 |
| 2008 | 0 | — | 0 | 65 |
| 2009 | 0 | — | 0 | 34 |
| 2010 | 0 | — | 11 | 27 |
| 2011 | 1 | — | 0 | 21 |
| 2012 | 2 | — | 0 | 34 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 1 | — | 4 | 10 |
| 2017 | 1 | — | 0 | 59 |
| 2018 | 0 | — | 0 | 309 |
| 2019 | 0 | — | 0 | 41 |
| 2020 | 0 | — | 0 | 30 |
| 2021 | 0 | — | 0 | 32 |
| 2022 | 1 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 108 |
| 2024 | 0 | — | 0 | 105 |
| 2025 | 0 | — | 1 | 339 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
The CONSTELLATION® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification, removal of cataracts, and intraocular lens injection) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. The AutoSert® IOL Injector Handpiece is intended to deliver qualified ACRYSOF® intraocular lenses into the eye…
Read the full statement (268 words)
The CONSTELLATION® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification, removal of cataracts, and intraocular lens injection) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. 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® 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.
Flex-Tip Laser Probes
• Retinal photocoagulation, panretinal photocoagulation and intravitreal photocoagulation of vascular and structural abnormalities of the retina and choroid including:
o Proliferative and nonproliferative retinopathy (including diabetic);
o Choroidal neovascularization secondary to age-related macular degeneration;
o Retinal tears and detachments;
o Macular edema;
o Retinopathy of prematurity;
o Choroidal neovascularization;
o Leaking microaneurysms.
• Iridotomy/Iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and Refractory Glaucoma.
• Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and refractory Glaucoma.
• And other laser treatments including:
o Internal sclerostomy;
o Lattice degeneration;
o Central and Branch Retinal Vein Occlusion;
o Suturelysis;
o Vascular and pigmented skin lesions.
UltraVit Probes
• Vitreous aspiration & cutting.
• Membrane cutting & aspiration.
• Lens removal.
Endoilluminator Probes
• Endoillumination
Valved Entry Systems
• Scleral incision
• Canulae for posterior segment instrument access
• Venting (of valved cannulae)
Infusion Cannulas
• Posterior segment infusion (liquid or gas)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141065 · printed Nov 4, 2026
Cite this page
510(k) Report. “K141065: Constellation Vision System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K141065
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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