# K023737: Injector

- Pathway: 510(k) (Traditional)
- Applicant: Anton Meyer & Co., Ltd.
- Decided: Jul 14, 2003 after 249 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 K930320 (1994). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011392: Micra Lens Injector, Micra Cartridge Lens, Micra Lens Loader, Micra Instruments (2001) Summary page 2.
- K003768: Monarch II Iol Delivery System, Alcon Research, Ltd. (2001) Summary page 2.
- K983129: Disposable Microstaar Injector (Model Msi-P1), Staar Surgical Co. (1998) Summary page 2.
- K961242: Amo Phacoflex II Intersection System, Allergan, Inc. (1996) Summary page 2.

## Most influential descendants
- K073010: Royale AE 9036 LSP Injector (2007), 0 descendants of its own

## Indications for use
The Royale®AE 9045 injector is intended as a reusable instrument to assist in implanting Alcon ACRYSOF® foldable intraocular lenses during a normal small incision cataract surgery. It is designed to incorporate Alcon cartridges Type C for foldable intraocular lenses. The cartridge is loaded into the injector body and by pushing the piston. The lens will be removed out of the cartridge and delivered to the desired position.

Source page: https://510kreport.com/device/K023737
Methodology: https://510kreport.com/methodology