# K101774: Monarch Iii Iol Delivery System; Monarch Iii P Catridge; Monarch Iii Handpiece (H4)

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Manufacturing, Ltd.
- Decided: Oct 13, 2011 after 476 days
- Product code: MSS (Folders And Injectors, Intraocular Lens (Iol))
- Device class: 1
- Regulation: 21 CFR 886.4300
- Recalls of this device: none
- 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.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

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

## Indications for use
This MONARCH III P 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/K101774
Methodology: https://510kreport.com/methodology