510(k) · Cleared
Recalled · 2010Alcon Vision System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon · HQC Unit, Phacofragmentation
Cleared on May 9, 2008 as substantially equivalent to K911808 (Alcon Laboratories, 1991) and 4 other predicates after a 526-day review. Its family tree reaches back 3 generations to 1985. 36 later devices descend from it. It has been recalled 11 times.
- Decided
- May 9, 2008
- Review
- 526 days
- Class
- Class II
- Product code
- HQC
- Recalls
- 11
- Predicates
- 5
Its longest line of descent runs back 3 generations to K844373 (1985). 14 ancestors in all. 36 later devices descend from it, 7 citing it directly.
- Root · 3 generations backK844373 O.M.S. Ultra-PhacoOptical Micro Systems, Inc. · 1985
- 2 generations backK981116 Sovereign Cataract Extraction SystemAllergan, Inc. · 1998 · Recalled
- 1 generation backK021566 InfinitiAlcon Laboratories, Inc. · 2002 · Recalled
- This deviceK063583 Alcon Vision SystemAlcon · 2008
- Descendant · cites it directly · 22 of its ownK082845 Infiniti Vision System with Ozil IPAlcon Research, Ltd. · 2009
- Descendant · cites it directly · 20 of its ownK091777 Alcon UltrachopperAlcon Research, Ltd. · 2009
- Descendant · cites it directly · 18 of its ownK093305 Enhanced Ultra Vit ProbeAlcon Research, Ltd. · 2010
- Descendant · cites it directly · 17 of its ownK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- Descendant · 2 generations on · 12 of its ownK102727 Lensar Laser System for Anterior CapsulotomyLensar, Inc. · 2011
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K082845Infiniti Vision System with Ozil IPAlcon Research, Ltd. · 2009 · cites it directly22descendants
- K091777Alcon UltrachopperAlcon Research, Ltd. · 2009 · cites it directly20descendants
- K093305Enhanced Ultra Vit ProbeAlcon Research, Ltd. · 2010 · cites it directly18descendants
- K101285Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · cites it directly17descendants
- K102727Lensar Laser System for Anterior CapsulotomyLensar, Inc. · 2011 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K844373 | O.M.S. Ultra-Phaco | Optical Micro Systems, Inc. | 1985 | — |
| −2 | K981116 | Sovereign Cataract Extraction System | Allergan, Inc. | 1998 | 1 |
| −1 | K021566 | Infiniti | Alcon Laboratories, Inc. | 2002 | 3 |
| 0 (this device) | K063583 | Alcon Vision System | Alcon | 2008 | — |
| +1 | K082845 | Infiniti Vision System with Ozil IP | Alcon Research, Ltd. | 2009 | — |
| +1 | K091777 | Alcon Ultrachopper | Alcon Research, Ltd. | 2009 | — |
| +1 | K093305 | Enhanced Ultra Vit Probe | Alcon Research, Ltd. | 2010 | — |
| +1 | K101285 | Constellation Vision System | Alcon Manufacturing, Ltd. | 2010 | 4 |
| +2 | K102727 | Lensar Laser System for Anterior Capsulotomy | Lensar, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2017 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K911808 | Gemini Ophthalmic Surgery SystemSummary page 1…Cutting Instrument (21 CFR 886.4150) Phacofragmentation System (21 CFR 886.4670) S.1. PredicateDevices 510(k) Number Device K911808 Alcon Accurus® Surgical System (Gemini Ophthalmic Surgery System) K9613 10 Storz Premiere® II/Bausch a… | 1991 |
| * | K961310 | Storz Premiere II Microsurgical System (CX Series)Summary page 1…n System (21 CFR 886.4670) S.1. PredicateDevices 510(k) Number Device K911808 Alcon Accurus® Surgical System (Gemini Ophthalmic Surgery System) K9613 10 Storz Premiere® II/Bausch and Lomb Millennium TM K021566 Alcon Infiniti® Vision System K981116… | 1996 |
| * | K021566 | InfinitiSummary page 1…Device K911808 Alcon Accurus® Surgical System (Gemini Ophthalmic Surgery System) K9613 10 Storz Premiere® II/Bausch and Lomb Millennium TM K021566 Alcon Infiniti® Vision System K981116 Allergan Sovereign® Cataract Extraction System K032598… | 2002 |
| * | K981116 | Sovereign Cataract Extraction SystemSummary page 1…ical System (Gemini Ophthalmic Surgery System) K9613 10 Storz Premiere® II/Bausch and Lomb Millennium TM K021566 Alcon Infiniti® Vision System K981116 Allergan Sovereign® Cataract Extraction System K032598 Synergetics Photon Illuminator 5.2. Device… | 1998 |
| * | K032598 | Synergetics Synerlight Fiber Optic LightsourceSummary page 1…Storz Premiere® II/Bausch and Lomb Millennium TM K021566 Alcon Infiniti® Vision System K981116 Allergan Sovereign® Cataract Extraction System K032598 Synergetics Photon Illuminator 5.2. Device Description The Alcon Vision System is a combined anterior and poster… | 2003 |
What descends from it? (36)
See all 367 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082845 | Infiniti Vision System with Ozil IP | 2009 | 22 |
| K091777 | Alcon Ultrachopper | 2009 | 20 |
| K093305 | Enhanced Ultra Vit Probe | 2010 | 18 |
| K101285 | Constellation Vision System | 2010 | 17 |
| K121555 | Centurion Vision System | 2012 | 6 |
| K110951 | 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved… | 2011 | 3 |
| 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 |
|---|---|---|---|---|
| Apr 30, 2010 | Not classified | Z-1933-2010 | Software design | Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues. |
| Apr 30, 2010 | Not classified | Z-1927-2010 | Software design | Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues. |
| Apr 30, 2010 | Not classified | Z-1925-2010 | Software design | Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues. |
| Apr 30, 2010 | Not classified | Z-1931-2010 | Software design | Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues. |
| Apr 30, 2010 | Not classified | Z-1924-2010 | Software design | Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues. |
| Apr 30, 2010 | Not classified | Z-1929-2010 | Software design | Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues. |
| Apr 30, 2010 | Not classified | Z-1934-2010 | Software design | Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues. |
| Apr 30, 2010 | Not classified | Z-1930-2010 | Software design | Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues. |
| Apr 30, 2010 | Not classified | Z-1928-2010 | Software design | Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues. |
| Apr 30, 2010 | Not classified | Z-1926-2010 | Software design | Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues. |
| Apr 30, 2010 | Not classified | Z-1932-2010 | Software design | Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues. |
The 5 latest of 11 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 23 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- 6 of the 14 ancestors have a recall of any class.
- Of its descendants, K082845 (Alcon Research, Ltd., 2009) has gone furthest, with 22 descendants of its own.
- 13 other devices also cite its predicate K911808.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Alcon 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/K063583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063583: Alcon 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/K063583
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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