# K003768: Monarch II Iol Delivery System

- Pathway: 510(k) (Abbreviated)
- Applicant: Alcon Research, Ltd.
- Decided: Jan 5, 2001 after 30 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
No predicates in its family tree.
45 later devices descend from it; 6 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K063155: Monarch Iii Iol Delivery System (2007), 28 descendants of its own
- K040837: Multiject Injector and Microglide Cartridge (2004), 25 descendants of its own
- K070669: Iol Injector Set (2007), 19 descendants of its own
- K092023: Naviject SUB2-1P, Model: LP604430 (2009), 18 descendants of its own
- K113852: Bausch & Lomb Iol Injector (2012), 12 descendants of its own

Source page: https://510kreport.com/device/K003768
Methodology: https://510kreport.com/methodology