# K070669: Iol Injector Set

- Pathway: 510(k) (Traditional)
- Applicant: Medicel AG
- Decided: Nov 1, 2007 after 234 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
Longest line of descent: 3 generations back to K930320 (1994). 5 ancestors in all.
19 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040837: Multiject Injector and Microglide Cartridge, Medicel AG (2004) Summary page 1.

## Most influential descendants
- K092023: Naviject SUB2-1P, Model: LP604430 (2009), 18 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
- K103495: Asico Softip Injector System (2011), 7 descendants of its own
- K142056: Lioli Iol Delivery System (2015), 6 descendants of its own

## Recalls of this device
- Aug 5, 2013 · Class II · Z-1984-2013: The firm initiated this recall of one lot (121402) of nanoPOINT Injectors after they noticed that Tyvek lids might have been damaged and, therefore, the stability of the sterile barrier might be negat

## Indications for use
The Medicel IOL Injector Set and Cartridge for intraocular lenses is indicated for the insertion only of models of intraocular lenses that allow use of this injector in their approved labeling.

Source page: https://510kreport.com/device/K070669
Methodology: https://510kreport.com/methodology