# K981116: Sovereign Cataract Extraction System

- Pathway: 510(k) (Traditional)
- Applicant: Allergan, Inc.
- Decided: May 19, 1998 after 53 days
- Product code: KYG (Device, Irrigation, Ocular Surgery)
- Device class: 1
- Regulation: 21 CFR 886.4360
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K844373 (1985). 5 ancestors in all.
59 later devices descend from it; 9 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971186: Amo Diplomax/Opsys Console, Allergan, Inc. (1997) Summary page 1.
- K946054: Diplomax, Optical Micro Systems, Inc. (1995) Summary page 1.
- K924235: Amo Elite, Allergan Medical Optics (1992) Summary page 1.
- K951462: Amo Profinesse Iii Ultrasonic Handpiece System, Allergan Medical Optics (1995) Summary page 1.
- K844373: O.M.S. Ultra-Phaco, Optical Micro Systems, Inc. (1985) Summary page 1.

## Most influential descendants
- K021566: Infiniti (2002), 50 descendants of its own
- K063583: Alcon Vision System (2008), 36 descendants of its own
- K063331: Bausch & Lomb NGX Microsurgical System (2006), 24 descendants of its own
- K082845: Infiniti Vision System with Ozil IP (2009), 22 descendants of its own
- K082473: Bausch & Lomb Stellaris Microsurgical System (2009), 22 descendants of its own

## Recalls of this device
- Sep 26, 2023 · Class II · Z-0130-2024: 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 ha

## Indications for use
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.

Source page: https://510kreport.com/device/K981116
Methodology: https://510kreport.com/methodology