# K123888: Z Cartridge Iol Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Aaren Scientific, Inc.
- Decided: Apr 15, 2013 after 118 days
- Product code: MSS (Folders And Injectors, Intraocular Lens (Iol))
- 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
Longest line of descent: 3 generations back to K001157 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112977: Monarch Iii Iol Delivery System, Monarch Iii C Cartridge, Monarch Iii Handpiece (H4), Alcon Research, Ltd. (2012) Summary page 3.

## Recalls of this device
- Sep 1, 2017 · Class II · Z-0071-2018: The recommended storage temperature on the label is incorrect.

## Indications for use
The Aero Z Cartridge IOL Delivery System is indicated to fold and insert Aaren Scientific IOLs that have the use of this inserter in their approved labeling.

Source page: https://510kreport.com/device/K123888
Methodology: https://510kreport.com/methodology