# K111446: Sovereign Compact Phacoemulsification System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Medical Optics, Inc.
- Decided: Dec 21, 2011 after 211 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- 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: 2 generations back to K844373 (1985). 10 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003638: Mojave Cataract Extraction System, Allergan, Inc. (2001) Summary page 2.
- K060366: The Amo Ophthalmic Surgical System, Advanced Medical Optics, Inc. (2006) Summary page 2.
- K981116: Sovereign Cataract Extraction System, Allergan, Inc. (1998) Summary page 1.

## Most influential descendants
- K133115: Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot Pedal, Single-Use Fluidics Pack (2014), 3 descendants of its own
- K151636: AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control (2015), 1 descendant of its own
- K203060: VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control (2021), 0 descendants of its own
- K151783: COMPACT INTUITIV Multiple-Use Pack (2015), 0 descendants of its own

## Recalls of this device
- May 23, 2013 · Class II · Z-1670-2013: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K111446
Methodology: https://510kreport.com/methodology