510(k) · Cleared
Recalled · Class II · 2023Constellation Vision System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Manufacturing, Ltd. · HQC Unit, Phacofragmentation
Cleared on Nov 12, 2010 as substantially equivalent to K063583 (Alcon, 2008) and 3 other predicates after a 189-day review. Its family tree reaches back 6 generations to 1994. 17 later devices descend from it. It has been recalled 4 times.
- Decided
- Nov 12, 2010
- Review
- 189 days
- Class
- Class II
- Product code
- HQC
- Recalls
- 4
- Predicates
- 4
Its longest line of descent runs back 6 generations to K933880 (1994). 40 ancestors in all, the oldest K844373 (1985). 17 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 5 generations backK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
- 4 generations backK964074 Diolite 532Iriderm Div. · 1997
- 3 generations backK982031 Oculight GL with the Dermatology HandpieceIridex Corp · 1998
- 2 generations backK031665 Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003
- 1 generation backK062624 Next Generation LaserAlcon Laboratories · 2007
- This deviceK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010
- Descendant · cites it directly · 6 of its ownK121555 Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · Recalled
- Descendant · cites it directly · 5 of its ownK142877 EVA,anterior machine, EVA, combined machine, EVA combined machine…Dutch Ophthalmic Research Center International BV · 2015
- Descendant · 2 generations on · 3 of its ownK161794 CENTURION Vision System (Active SentryTM)Alcon Research, Ltd. · 2017
- Descendant · cites it directly · 3 of its ownK110951 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator…Alcon Research, Ltd. · 2011 · Recalled
- Descendant · cites it directly · 2 of its ownK190875 EVA, anterior machine, EVA, combined machine, EVA combined machine…D.O.R.C. Dutch Ophthalmic Research Center (International) · 2019 · Recalled
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K121555Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · cites it directly6descendants
- K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Dutch Ophthalmic Research Center International BV · 2015 · cites it directly5descendants
- K161794CENTURION Vision System (Active SentryTM)Alcon Research, Ltd. · 2017 · 2 generations on3descendants
- K11095127+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved…Alcon Research, Ltd. · 2011 · cites it directly3descendants
- K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…D.O.R.C. Dutch Ophthalmic Research Center (International) · 2019 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933880 | SL Series Surgical Laser Systems | Laserscope | 1994 | — |
| −5 | K954905 | CB Diode/532 Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −4 | K964074 | Diolite 532 | Iriderm Div. | 1997 | — |
| −3 | K982031 | Oculight GL with the Dermatology Handpiece | Iridex Corp | 1998 | — |
| −2 | K031665 | Iris Medical Oculight GL/GLX Laser Systems | Iridex Corp | 2003 | — |
| −1 | K062624 | Next Generation Laser | Alcon Laboratories | 2007 | — |
| 0 (this device) | K101285 | Constellation Vision System | Alcon Manufacturing, Ltd. | 2010 | — |
| +1 | K121555 | Centurion Vision System | Alcon Laboratories, Inc. | 2012 | 4 |
| +1 | K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser… | Dutch Ophthalmic Research Center International BV | 2015 | — |
| +2 | K161794 | CENTURION Vision System (Active SentryTM) | Alcon Research, Ltd. | 2017 | — |
| +1 | K110951 | 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+… | Alcon Research, Ltd. | 2011 | 1 |
| +1 | K190875 | EVA, anterior machine, EVA, combined machine, EVA combined machine with laser… | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2019 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 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 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? (4)
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 |
|---|---|---|---|
| * | K063583 | Alcon Vision SystemSummary page 1…ion & Cuffing Instrument (21 CFR 886.4150) Phacofragmentation System (21 CFR 886.4670) Predicate Devices 510(k) Number Device K063583 Alcon Vision System K091777 Alcon UltraChopper K093305 Enhanced UltraVit Probe K0626… | 2008 |
| * | K091777 | Alcon UltrachopperSummary page 1…Phacofragmentation System (21 CFR 886.4670) Predicate Devices 510(k) Number Device K063583 Alcon Vision System K091777 Alcon UltraChopper K093305 Enhanced UltraVit Probe K062604 Next Generation Laser… | 2009 |
| * | K093305 | Enhanced Ultra Vit ProbeSummary page 1…mentation System (21 CFR 886.4670) Predicate Devices 510(k) Number Device K063583 Alcon Vision System K091777 Alcon UltraChopper K093305 Enhanced UltraVit Probe K062604 Next Generation Laser… | 2010 |
| * | K062624 | Next Generation Laser Our reading of the summary gave K062604, FDA’s number for Rapidteg Teg-Act Test (Haemoscope Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Next Generation Laser”. | 2007 |
What descends from it? (17)
See all 175 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121555 | Centurion Vision System | 2012 | 6 |
| K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC… | 2015 | 5 |
| K110951 | 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved… | 2011 | 3 |
| K190875 | EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC… | 2019 | 2 |
| K141065 | Constellation Vision System | 2014 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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… |
| Jul 25, 2018 | Class II | Z-1794-2020 | Employee error | There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a 20-gauge infusion cannula. |
| Jan 12, 2018 | Class II | Z-0778-2018 | Employee error | Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vitrectomy Pak due a potential that a 23GA ULTRAVIT probe may be included within the 25+ TOTALPLUS Vitrectomy Pak, instead of a… |
| Jan 12, 2018 | Class II | Z-0779-2018 | Employee error | Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vitrectomy Pak due a potential that a 23GA ULTRAVIT probe may be included within the 25+ TOTALPLUS Vitrectomy Pak, instead of a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 10 of the 40 ancestors have a recall of any class.
- Of its descendants, K121555 (Alcon Laboratories, Inc., 2012) has gone furthest, with 6 descendants of its own.
- 6 other devices also cite its predicate K063583.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Constellation® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101285: Constellation 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/K101285
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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