# K970727: Mport Foldable Lens Placement System

- Pathway: 510(k) (Traditional)
- Applicant: Chiron Vision Corp.
- Decided: Dec 17, 1997 after 292 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: 1 generation back to K914311 (1992). 1 ancestor in all.
17 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914311: Chiroflex II Lens Microsert (TM), Chiron Ophthalmics (1992) Summary page 1.

## Most influential descendants
- K052651: C-Flex System Single Use Disposable Injector, Model R-Inj-02 (2006), 10 descendants of its own
- K062612: Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04 (2006), 5 descendants of its own
- K091507: Rayner Small Incision Single Use Soft Tipped Injector, Model R-Inj-04/18 (2009), 3 descendants of its own
- K090161: Epiphany Injection System (2009), 3 descendants of its own
- K082944: Crystalsert Crystalens Delivery System (2008), 3 descendants of its own

## Recalls of this device
- Apr 5, 2017 · Class II · Z-2098-2017: Complaints concerning kinked haptics that were occurring during lens delivery.

## Indications for use
The Mport™ Foldable Lens Placement System is a Class | device indicated for compressing and inserting a Soflex™ (formerly Chirofiex Il) series multi-piece intraocular lens into the eye during small incision cataract surgery.

Source page: https://510kreport.com/device/K970727
Methodology: https://510kreport.com/methodology