# K970033: Monarch Iol Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Laboratories
- Decided: Apr 23, 1997 after 110 days
- Product code: KYB (Lens, Guide, Intraocular)
- 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: 1 generation back to K903574 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903574: Chiroflex Lens Microsert, Chiron Ophthalmics (1990) Summary page 2.
- K913626: Softrans Injector, Staar Surgical Co. (1991) Summary page 2.

## Indications for use
The intended use of this device is to fold and deliver Alcon ACRYSOF® intraocular lenses into the eye for replacement of the human crystalline lens.

Source page: https://510kreport.com/device/K970033
Methodology: https://510kreport.com/methodology