510(k) · Cleared

Recalled · Class II · 2017

Mport Foldable Lens Placement System

K970727510(k) TraditionalCleared Dec 17, 1997292-day reviewClass I21 CFR 886.4300Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Chiron Vision Corp. · MSS Folders And Injectors, Intraocular Lens (Iol)

Cleared on Dec 17, 1997 as substantially equivalent to K914311 (Chiron Ophthalmics, 1992) after a 292-day review. Its family tree reaches back 1 generation to 1992. 17 later devices descend from it. It has been recalled once.

Decided: Dec 17, 1997
Review: 292 days
Class: Class I
Product code: MSS
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K914311 (1992). 17 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK914311 Chiroflex II Lens Microsert (TM)Chiron Ophthalmics · 1992
This deviceK970727 Mport Foldable Lens Placement SystemChiron Vision Corp. · 1997
Descendant · cites it directly · 10 of its ownK052651 C-Flex System Single Use Disposable Injector, Model R-Inj-02Rayner Surgical, Inc. · 2006
Descendant · 2 generations on · 5 of its ownK062612 Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04Rayner Surgical, Inc. · 2006
Descendant · 3 generations on · 3 of its ownK091507 Rayner Small Incision Single Use Soft Tipped Injector, Model…Rayner Intraocular Lenses, Ltd. · 2009
Descendant · cites it directly · 3 of its ownK090161 Epiphany Injection SystemStaar Surgical Co. · 2009
Descendant · cites it directly · 3 of its ownK082944 Crystalsert Crystalens Delivery SystemBausch & Lomb, Inc. · 2008

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2006high 3 (2013) · low 0 (2007)2026

Most influential descendants

Showing 5 of 17 · See all

K052651C-Flex System Single Use Disposable Injector, Model R-Inj-02Rayner Surgical, Inc. · 2006 · cites it directly10descendants
K062612Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04Rayner Surgical, Inc. · 2006 · 2 generations on5descendants
K091507Rayner Small Incision Single Use Soft Tipped Injector, Model R-Inj-04/18Rayner Intraocular Lenses, Ltd. · 2009 · 3 generations on3descendants
K090161Epiphany Injection SystemStaar Surgical Co. · 2009 · cites it directly3descendants
K082944Crystalsert Crystalens Delivery SystemBausch & Lomb, Inc. · 2008 · cites it directly3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K914311	Chiroflex II Lens Microsert (TM)	Chiron Ophthalmics	1992	—
0 (this device)	K970727	Mport Foldable Lens Placement System	Chiron Vision Corp.	1997	—
+1	K052651	C-Flex System Single Use Disposable Injector, Model R-Inj-02	Rayner Surgical, Inc.	2006	—
+2	K062612	Rayner Single Use Soft Tipped Disposable Injector, Model R-Inj-04	Rayner Surgical, Inc.	2006	—
+3	K091507	Rayner Small Incision Single Use Soft Tipped Injector, Model R-Inj-04/18	Rayner Intraocular Lenses, Ltd.	2009	—
+1	K090161	Epiphany Injection System	Staar Surgical Co.	2009	—
+1	K082944	Crystalsert Crystalens Delivery System	Bausch & Lomb, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0
2008	2	0
2009	2	0
2010	1	0
2013	3	0
2014	3	0
2015	1	0
2016	1	0
2017	2	0

FIG. 1 — Lineage of K970727, 1992–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MSS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MSS device

#1 K261174 RxSight® Insertion Devicescore 15.1 · 13 generations · no Class I recall
#2 Held for the reportin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K914311	Chiroflex II Lens Microsert (TM) Summary page 1 …rketed device or devices to which substantial equivalence is being claimed: Company: Chiron Vision Corporation Device: Microsert™ Foldable Lens Placement System 510(k) K914311 Date Cleared June 2, 1995 Page 7 —— Chiron Vision Corporation Mport™ Foldable Lens Placement System K TOTZ ]…	Chiron Ophthalmics	1992	—

What descends from it? (17)

See all 17

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K052651	C-Flex System Single Use Disposable Injector, Model R-Inj-02	Rayner Surgical, Inc.	2006	10
K090161	Epiphany Injection System	Staar Surgical Co.	2009	3
K082944	Crystalsert Crystalens Delivery System	Bausch & Lomb, Inc.	2008	3
K132481	Easy-Load Lens Delivery System	Bausch & Lomb	2013	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 5, 2017	Class II	Z-2098-2017	Device Design	Complaints concerning kinked haptics that were occurring during lens delivery.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K052651 (Rayner Surgical, Inc., 2006) has gone furthest, with 10 descendants of its own.

How does its category compare?

All MSS devices

MSS Folders And Injectors, Intraocular Lens (Iol): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MSS

1in 2025

2007high 5 (2008) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MSS

54in 2023

2007high 197 (2009) · low 30 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MSS

1in 2017

2007high 1 (2016) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MSS

429in 2025

2007high 490 (2022) · low 95 (2011)2025

MAUDE reports naming product code MSS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	445
2008	5	84	0	185
2009	5	197	0	186
2010	2	—	0	203
2011	2	—	0	95
2012	2	—	0	129
2013	5	141	0	203
2014	5	78	0	114
2015	3	156	0	127
2016	2	—	1	112
2017	3	30	1	114
2018	1	—	0	340
2019	3	67	0	271
2020	2	—	0	362
2021	1	—	0	289
2022	0	—	0	490
2023	3	54	0	330
2024	1	—	0	375
2025	1	—	0	429
2026	1	—	0	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K970727 · printed Nov 6, 2026

Cite this page

510(k) Report. “K970727: Mport Foldable Lens Placement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970727

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026