510(k) · Cleared
Recalled · Class II · 2025Unity VCS (8065000296); Unity CS (8065000297)
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 Jun 21, 2024 as substantially equivalent to K141065 (Alcon Research, Ltd., 2014) and 2 other predicates after a 197-day review. Its family tree reaches back 9 generations to 1994. It has been recalled 2 times.
- Decided
- Jun 21, 2024
- Review
- 197 days
- Class
- Class II
- Product code
- HQC
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 9 generations to K933880 (1994). 62 ancestors in all, the oldest K842458 (1984). No later device cites it as a predicate yet.
- Root · 9 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 5 generations between
- 3 generations backK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- 2 generations backK121555 Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · Recalled
- 1 generation backK141065 Constellation Vision SystemAlcon Research, Ltd. · 2014 · Recalled
- This deviceK233876 Unity VCS (8065000296); Unity CS (8065000297)Alcon Laboratories, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 8 generations backK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
- 7 generations backK964074 Diolite 532Iriderm Div. · 1997
- 6 generations backK982031 Oculight GL with the Dermatology HandpieceIridex Corp · 1998
- 5 generations backK031665 Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003
- 4 generations backK062624 Next Generation LaserAlcon Laboratories · 2007
- 3 generations backK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- 2 generations backK121555 Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · Recalled
- 1 generation backK141065 Constellation Vision SystemAlcon Research, Ltd. · 2014 · Recalled
- This deviceK233876 Unity VCS (8065000296); Unity CS (8065000297)Alcon Laboratories, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K933880 | SL Series Surgical Laser Systems | Laserscope | 1994 | — |
| −8 | K954905 | CB Diode/532 Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −7 | K964074 | Diolite 532 | Iriderm Div. | 1997 | — |
| −6 | K982031 | Oculight GL with the Dermatology Handpiece | Iridex Corp | 1998 | — |
| −5 | K031665 | Iris Medical Oculight GL/GLX Laser Systems | Iridex Corp | 2003 | — |
| −4 | K062624 | Next Generation Laser | Alcon Laboratories | 2007 | — |
| −3 | K101285 | Constellation Vision System | Alcon Manufacturing, Ltd. | 2010 | 4 |
| −2 | K121555 | Centurion Vision System | Alcon Laboratories, Inc. | 2012 | 4 |
| −1 | K141065 | Constellation Vision System | Alcon Research, Ltd. | 2014 | 6 |
| 0 (this device) | K233876 | Unity VCS (8065000296); Unity CS (8065000297) | Alcon Laboratories, Inc. | 2024 | — |
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 |
| 2017 | 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? (3)
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 |
|---|---|---|---|
| * | K141065 | Constellation Vision SystemSummary page 6…6.4670, Phacofragmentation system (HQC) Regulatory Class II 3. PREDICATE DEVICES FOR UNITY VCS: Predicate Device CONSTELLATION Vision System 510(k) Number K141065 Classification • 21 CFR 886.4150, Vitreous aspiration and cutting instrument Number and Name (HQE) (Product Code… | 2014 |
| * | K062624 | Next Generation LaserSummary page 6…70, Phacofragmentation system (HQC) Parentheses) Regulatory Class II FOR UNITY VCS (Laser Functionality): Predicate Device Next-Generation Laser 510(k) Number K062624 Classification • 21 CFR 886.4390, Laser, Ophthalmic (HQF) Number and Name (Product Code in Parentheses) Regulatory Class… | 2007 |
| * | K161794 | CENTURION Vision System (Active SentryTM)Summary page 6…) Number and Name (Product Code in Parentheses) Regulatory Class II FOR UNITY CS: Predicate Device CENTURION Vision System with Active Sentry 510(k) Number K161794 Classification 21 CFR 886.4670, Phacofragmentation system (HQC)… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 19 of the 62 ancestors have a recall of any class.
- 1 other device also cites its predicate K141065.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
UNITY VCS
The UNITY VCS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery.
In addition, with the optional laser this system is indicated for photocoagulation (i.e. vitreoretinal and macular pathologies), iridotomy, and trabeculoplasty procedures.
UNITY CS
The UNITY CS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) ophthalmic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233876 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233876: Unity VCS (8065000296); Unity CS (8065000297).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233876
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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