# K112977: Monarch Iii Iol Delivery System, Monarch Iii C Cartridge, Monarch Iii Handpiece (H4)

- Pathway: 510(k) (Abbreviated)
- Applicant: Alcon Research, Ltd.
- Decided: Mar 27, 2012 after 173 days
- Product code: MSS (Folders And Injectors, Intraocular Lens (Iol))
- 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: 2 generations back to K001157 (2000). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001157: Monarch II Iol Delivery System, Alcon Research, Ltd. (2000)
- K003768: Monarch II Iol Delivery System, Alcon Research, Ltd. (2001) Summary page 2.
- K063155: Monarch Iii Iol Delivery System, Alcon Manufacturing, Ltd. (2007) Summary page 1.

## Most influential descendants
- K212039: CLAREON MONARCH IV IOL Delivery System (2021), 0 descendants of its own
- K123888: Z Cartridge Iol Delivery System (2013), 0 descendants of its own

## Recalls of this device
- Sep 5, 2016 · Class II · Z-0978-2017: The intraocular lens could become lodged within the cartridge

## Indications for use
This Monarch® III C Cartridge IOL insertion device is indicated to fold/hold and insert Alcon IOLs that have the use of this inserter in their approved labeling.

Source page: https://510kreport.com/device/K112977
Methodology: https://510kreport.com/methodology