# K980696: Foam Tip Injector

- Pathway: 510(k) (Traditional)
- Applicant: Staar Surgical Co.
- Decided: Sep 11, 1998 after 200 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
No predicates in its family tree.
16 later devices descend from it; 3 cite it directly.
0 of 17 devices 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) MicroSTAAR™ Injector System (reusable and disposable): named in the summary without a submission number

## Most influential descendants
- K050638: Lenstec Intraocular Lens (Iol) Injection System for Tetraflex Intraocular Lenses (2005), 12 descendants of its own
- K060533: Lenstec Intraocular Lens (Iol) Injection System (2006), 11 descendants of its own
- K063802: Lenstec LC Injection System (2007), 10 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
- Apr 21, 2004 · Not classified · Z-0957-04: Cracking of the distal end of the injector occurs during locking of the cartridge into the nose cone of the injector.

## Indications for use
The Foam Tip™ Injector is a device used to fold and insert STAAR Surgical UV-ELASTIC™ single-piece silicone lenses for surgical placement in the human eye. There are no marketing claims for this device at this time.

Source page: https://510kreport.com/device/K980696
Methodology: https://510kreport.com/methodology