510(k) · Cleared

Recalled · Class II · 2023

Sovereign Cataract Extraction System

K981116510(k) TraditionalCleared May 19, 199853-day reviewClass I21 CFR 886.4360Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Allergan, Inc. · KYG Device, Irrigation, Ocular Surgery

Cleared on May 19, 1998 as substantially equivalent to K971186 (Allergan, Inc., 1997) and 4 other predicates after a 53-day review. Its family tree reaches back 1 generation to 1985. 59 later devices descend from it. It has been recalled once.

Decided: May 19, 1998
Review: 53 days
Class: Class I
Product code: KYG
Recalls: 1
Predicates: 5

Its longest line of descent runs back 1 generation to K844373 (1985). 5 ancestors in all. 59 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 1 generation backK844373 O.M.S. Ultra-PhacoOptical Micro Systems, Inc. · 1985
This deviceK981116 Sovereign Cataract Extraction SystemAllergan, Inc. · 1998
Descendant · cites it directly · 50 of its ownK021566 InfinitiAlcon Laboratories, Inc. · 2002 · Recalled
Descendant · cites it directly · 36 of its ownK063583 Alcon Vision SystemAlcon · 2008 · Recalled
Descendant · 2 generations on · 24 of its ownK063331 Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · Recalled
Descendant · cites it directly · 22 of its ownK082845 Infiniti Vision System with Ozil IPAlcon Research, Ltd. · 2009
Descendant · 3 generations on · 22 of its ownK082473 Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 2009 · Recalled

Showing 5 of 59 descendants. See all descendants

Descendants cleared per year

2002high 7 (2017) · low 0 (2007)2026

Most influential descendants

Showing 5 of 59 · See all

K021566InfinitiAlcon Laboratories, Inc. · 2002 · cites it directly50descendants
K063583Alcon Vision SystemAlcon · 2008 · cites it directly36descendants
K063331Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · 2 generations on24descendants
K082845Infiniti Vision System with Ozil IPAlcon Research, Ltd. · 2009 · cites it directly22descendants
K082473Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 2009 · 3 generations on22descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K844373	O.M.S. Ultra-Phaco	Optical Micro Systems, Inc.	1985	—
0 (this device)	K981116	Sovereign Cataract Extraction System	Allergan, Inc.	1998	—
+1	K021566	Infiniti	Alcon Laboratories, Inc.	2002	3
+1	K063583	Alcon Vision System	Alcon	2008	11
+2	K063331	Bausch & Lomb NGX Microsurgical System	Bausch & Lomb, Inc.	2006	12
+1	K082845	Infiniti Vision System with Ozil IP	Alcon Research, Ltd.	2009	—
+3	K082473	Bausch & Lomb Stellaris Microsurgical System	Bausch & Lomb, Inc.	2009	4

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1995	2	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	1	0
2005	1	0
2006	1	0
2008	1	0
2009	4	0
2010	4	0
2011	5	0
2012	4	0
2013	1	0
2014	6	0
2015	6	0
2017	7	0
2019	2	0
2020	2	0
2021	1	0
2022	3	0
2023	1	0
2024	5	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K981116, 1985–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 KYG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) 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	Applicant	Decided	Recalls
*	K971186	Amo Diplomax/Opsys Console Summary page 1 …s 510(k), Sovereign™ Cataract Extraction System, is substantially equivalent to the other AMO® cataract extraction devices which were authorized for marketing via 510(k) K971186 (AMO®Diplomax® System-modified), K946054 (AMO®Diplomax® System), and K924235 (AMO®Prestige® system). The handpiece component of t…	Allergan, Inc.	1997	—
*	K946054	Diplomax Summary page 1 …System, is substantially equivalent to the other AMO® cataract extraction devices which were authorized for marketing via 510(k) K971186 (AMO®Diplomax® System-modified), K946054 (AMO®Diplomax® System), and K924235 (AMO®Prestige® system). The handpiece component of the Sovereign™ system is equivalent to ult…	Optical Micro Systems, Inc.	1995	—
*	K924235	Amo Elite Summary page 1 …to the other AMO® cataract extraction devices which were authorized for marketing via 510(k) K971186 (AMO®Diplomax® System-modified), K946054 (AMO®Diplomax® System), and K924235 (AMO®Prestige® system). The handpiece component of the Sovereign™ system is equivalent to ultrasonic handpieces authorized for ma…	Allergan Medical Optics	1992	1
*	K951462	Amo Profinesse Iii Ultrasonic Handpiece System Summary page 1 …ystem), and K924235 (AMO®Prestige® system). The handpiece component of the Sovereign™ system is equivalent to ultrasonic handpieces authorized for marketing under 510(k) K951462 (AMO®ProFicient® Handpiece), and K844373 (AMO®Series III® Handpiece). The manufacturer of the predicate devices is Allergan. The…	Allergan Medical Optics	1995	1
*	K844373	O.M.S. Ultra-Phaco Summary page 1 …). The handpiece component of the Sovereign™ system is equivalent to ultrasonic handpieces authorized for marketing under 510(k) K951462 (AMO®ProFicient® Handpiece), and K844373 (AMO®Series III® Handpiece). The manufacturer of the predicate devices is Allergan. The significant changes to the predicate dev…	Optical Micro Systems, Inc.	1985	—

What descends from it? (59)

See all 59

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K021566	Infiniti	Alcon Laboratories, Inc.	2002	50
K063583	Alcon Vision System	Alcon	2008	36
K082845	Infiniti Vision System with Ozil IP	Alcon Research, Ltd.	2009	22
K111446	Sovereign Compact Phacoemulsification System	Abbott Medical Optics, Inc.	2011	4
K133115	Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot Pedal, Single-Use…	Abbott Medical Optics, Inc.	2014	3
K151783	COMPACT INTUITIV Multiple-Use Pack	Abbott Medical Optics, Inc.	2015	0
K050648	Sovereign High Vacuum Pack, Sovereign Compact High Vacuum Pack	Advanced Medical Optics, Inc.	2005	0
K033941	Millennium Microsurgical System and Peristaltic Phaco Pack	Bausch & Lomb, Inc.	2004	0
K031404	Dignity Ophthalmic Surgical System	Phacor Inc., A Santen Company	2003	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 26, 2023	Class II	Z-0130-2024	Process control	Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 5 ancestors have a recall of any class.
Of its descendants, K021566 (Alcon Laboratories, Inc., 2002) has gone furthest, with 50 descendants of its own.

How does its category compare?

All KYG devices

KYG Device, Irrigation, Ocular Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KYG

FDA has decided no KYG device since 2007.

Median 510(k) review, days · KYG

Too few KYG 510(k)s in any year since 2007 to give a median.

Recalls per year · KYG

1in 2023

2007high 4 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KYG

72in 2025

2007high 332 (2012) · low 8 (2020)2025

MAUDE reports naming product code KYG, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	4	103
2008	—	0	61
2009	—	0	50
2010	—	2	127
2011	—	0	81
2012	—	0	332
2013	—	0	242
2014	—	0	258
2015	—	0	79
2016	—	0	14
2017	—	0	10
2018	—	0	10
2019	—	0	13
2020	—	0	8
2021	—	0	19
2022	—	0	20
2023	—	1	23
2024	—	0	81
2025	—	0	72
2026	—	0	—

What is it indicated for?

The Sovereign™ Cataract Extraction System is a phacofragmentation system for use with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract. The Sovereign™ Cataract Extraction System is designed to provide the surgical capabilities desired by the Anterior Segment/Cataract Surgeon for use in the cataract extraction.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K981116 · printed Nov 5, 2026

Cite this page

510(k) Report. “K981116: Sovereign Cataract Extraction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981116

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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