# K001157: Monarch II Iol Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Research, Ltd.
- Decided: Jun 27, 2000 after 78 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
No predicates in its family tree.
30 later devices descend from it; 3 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)
- 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
- 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

## Recalls of this device
- Jul 7, 2008 · Not classified · Z-2441-2008: Delivery cartridge for implanting intraocular lenses is mislabeled and may result in complicated insertion and damage to the lens.

Source page: https://510kreport.com/device/K001157
Methodology: https://510kreport.com/methodology