# K063155: Monarch Iii Iol Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Manufacturing, Ltd.
- Decided: Mar 27, 2007 after 161 days
- Product code: KYB (Lens, Guide, Intraocular)
- Device class: 1
- Regulation: 21 CFR 886.4300
- 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 K001157 (2000). 2 ancestors in all.
28 later devices descend from it; 7 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003768: Monarch II Iol Delivery System, Alcon Research, Ltd. (2001) Summary page 1.
- K001157: Monarch II Iol Delivery System, Alcon Research, Ltd. (2000) Summary page 1.

## Most influential descendants
- K113852: Bausch & Lomb Iol Injector (2012), 12 descendants of its own
- K131958: Bausch & Lomb Injector System (2014), 9 descendants of its own
- K112425: Infiniti Vision System Evergreen II Autosert Iol Injector Handpiece (2011), 8 descendants of its own
- K121555: Centurion Vision System (2012), 6 descendants of its own
- K151102: Bausch + Lomb Injector System (2015), 5 descendants of its own

## Recalls of this device
- Nov 13, 2024 · Class II · Z-0835-2025: Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (IOL) upon delivery.

## Indications for use
The MONARCH® III IOL Delivery System is used for implantation of ALCON® qualified ACRYSOF® intraocular lenses into the eye following cataract removal.

Source page: https://510kreport.com/device/K063155
Methodology: https://510kreport.com/methodology