510(k) · Cleared
Recalled · Class II · 2013Sovereign Compact Phacoemulsification System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical Optics, Inc. · HQC Unit, Phacofragmentation
Cleared on Dec 21, 2011 as substantially equivalent to K003638 (Allergan, Inc., 2001) and 2 other predicates after a 211-day review. Its family tree reaches back 2 generations to 1985. 4 later devices descend from it. It has been recalled once.
- Decided
- Dec 21, 2011
- Review
- 211 days
- Class
- Class II
- Product code
- HQC
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K844373 (1985). 10 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK844373 O.M.S. Ultra-PhacoOptical Micro Systems, Inc. · 1985
- 1 generation backK981116 Sovereign Cataract Extraction SystemAllergan, Inc. · 1998 · Recalled
- This deviceK111446 Sovereign Compact Phacoemulsification SystemAbbott Medical Optics, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK133115 Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot…Abbott Medical Optics, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK151636 AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR…Abbott Medical Optics, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK203060 VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack…Johnson & Johnson Surgical Vision, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK151783 COMPACT INTUITIV Multiple-Use PackAbbott Medical Optics, Inc. · 2015
Most influential descendants
Showing 4 of 4 · See all- K133115Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot Pedal, Single-Use…Abbott Medical Optics, Inc. · 2014 · cites it directly3descendants
- K151636AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance…Abbott Medical Optics, Inc. · 2015 · 2 generations on1descendant
- K203060VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced…Johnson & Johnson Surgical Vision, Inc. · 2021 · 3 generations on0descendants
- K151783COMPACT INTUITIV Multiple-Use PackAbbott Medical Optics, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K844373 | O.M.S. Ultra-Phaco | Optical Micro Systems, Inc. | 1985 | — |
| −1 | K981116 | Sovereign Cataract Extraction System | Allergan, Inc. | 1998 | 1 |
| 0 (this device) | K111446 | Sovereign Compact Phacoemulsification System | Abbott Medical Optics, Inc. | 2011 | — |
| +1 | K133115 | Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot Pedal… | Abbott Medical Optics, Inc. | 2014 | 1 |
| +2 | K151636 | AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature… | Abbott Medical Optics, Inc. | 2015 | — |
| +3 | K203060 | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and… | Johnson & Johnson Surgical Vision, Inc. | 2021 | 3 |
| +2 | K151783 | COMPACT INTUITIV Multiple-Use Pack | Abbott Medical Optics, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K003638 | Mojave Cataract Extraction SystemSummary page 2…c scientific concepts, physical properties and intended use of The System are identical to those of The Mojave Cataract Extraction System (branded as Sovereign Compact) (K003638) predicate device, The AMO Ophthalmic Surgical System was also listed as a predicate because it shares the same available softwar… | 2001 |
| * | K060366 | The Amo Ophthalmic Surgical SystemSummary page 2…of the device are substantially equivalent to those cleared under the 510(k)s of the Mojave Cataract Extraction System (K003638) and the AMO Ophthalmic Surgical System (K060366). The technological characteristics of the AMO Ultrasonic Handpiece are substantially equivalent to those of the Sovereign Phaco… | 2006 |
| * | K981116 | Sovereign Cataract Extraction SystemSummary page 1…stem __________ AMO Ultrasonic Handipiece 690880 Predicate Device Svrinhco SvrinHandpiece ic AMO I1K981116 0 O5/19/1998 A… | 1998 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133115 | Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot Pedal, Single-Use… | 2014 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 23, 2013 | Class II | Z-1670-2013 | Software design | Abbott Medical Optics Inc. (AMO) initiated this Urgent Notice of Medical Device Correction and Advisory Notice to all customers who use the AMO Sovereign¿ Compact Phacoemulsification System, Version 5.3, because it has the potential to… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 13.6 years on median.
- 6 of the 10 ancestors have a recall of any class.
- Of its descendants, K133115 (Abbott Medical Optics, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K003638.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Sovereign Compact Phacoemulsification System is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111446 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111446: Sovereign Compact Phacoemulsification System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111446
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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