# K981571: Monarch Iol Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Laboratories
- Decided: Jul 9, 1998 after 66 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MONARCH IOL Delivery System: named in the summary without a submission number
- (no number) ChiroFlex Lens Microsert: named in the summary without a submission number
- (no number) Softrans Injector: named in the summary without a submission number

## 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/K981571
Methodology: https://510kreport.com/methodology