510(k) Report

510(k) · Cleared

Cleared

Microstaar Msi Injector System Cartridge

K101782510(k) SpecialCleared Dec 22, 2010180-day reviewClass I21 CFR 886.4300

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

Staar Japan · MSS Folders And Injectors, Intraocular Lens (Iol)

Cleared on Dec 22, 2010 as substantially equivalent to K090161 (Staar Surgical Co., 2009) and 3 other predicates after a 180-day review. Its family tree reaches back 4 generations to 1992. 2 later devices descend from it.

Decided
Dec 22, 2010
Review
180 days
Class
Class I
Product code
MSS
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K914311 (1992). 10 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 2 other ancestors1998: 1 other ancestor1994: 1 other ancestor2000: 1 other ancestor1995: 1 other ancestor2017: 1 descendant cleared2015: 1 descendant clearedK914311 · Chiroflex II Lens Microsert (TM) · Chiron Ophthalmics · 1992K970727 · Mport Foldable Lens Placement System · Chiron Vision Corp. · 1997 · recalledK052651 · C-Flex System Single Use Disposable Injector, Model R-Inj-02 · Rayner Surgical, Inc. · 2006K090161 · Epiphany Injection System · Staar Surgical Co. · 20091990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors 1 generation forward: 2 descendants K090161 · Epiphany Injection System · Staar Surgical Co. · 2009K052651 · C-Flex System Single Use Disposable Injector, Model R-Inj-02 · Rayner Surgical, Inc. · 2006K970727 · Mport Foldable Lens Placement System · Chiron Vision Corp. · 1997 · recalledK914311 · Chiroflex II Lens Microsert (TM) · Chiron Ophthalmics · 19920
  1. Root · 4 generations backK914311 Chiroflex II Lens Microsert (TM)Chiron Ophthalmics · 1992
  2. 3 generations backK970727 Mport Foldable Lens Placement SystemChiron Vision Corp. · 1997 · Recalled
  3. 2 generations backK052651 C-Flex System Single Use Disposable Injector, Model R-Inj-02Rayner Surgical, Inc. · 2006
  4. 1 generation backK090161 Epiphany Injection SystemStaar Surgical Co. · 2009
  5. This deviceK101782 Microstaar Msi Injector System CartridgeStaar Japan · 2010
  6. Descendant · cites it directly · 0 of its ownK172375 MicroSTAAR Injector System CartridgesSTAAR Surgical Company · 2017
  7. Descendant · cites it directly · 0 of its ownK152357 MicroSTAAR Injector System CartridgesSTAAR Surgical Company · 2015

Most influential descendants

Showing 2 of 2 · See all
  • K172375MicroSTAAR Injector System CartridgesSTAAR Surgical Company · 2017 · cites it directly0descendants
  • K152357MicroSTAAR Injector System CartridgesSTAAR Surgical Company · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K914311Chiroflex II Lens Microsert (TM)Chiron Ophthalmics1992—
−3K970727Mport Foldable Lens Placement SystemChiron Vision Corp.19971
−2K052651C-Flex System Single Use Disposable Injector, Model R-Inj-02Rayner Surgical, Inc.2006—
−1K090161Epiphany Injection SystemStaar Surgical Co.2009—
0 (this device)K101782Microstaar Msi Injector System CartridgeStaar Japan2010—
+1K172375MicroSTAAR Injector System CartridgesSTAAR Surgical Company2017—
+1K152357MicroSTAAR Injector System CartridgesSTAAR Surgical Company2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510
199810
200010
200820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201710
FIG. 1 — Lineage of K101782, 1992–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261174 RxSight® Insertion Devicescore 15.1 · 13 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K090161Epiphany Injection System
Summary page 1
…ns Injector Cartridge MicroSTAAR™ MSI Injector System Models: CQ, SFC 25, SFC 45 The primary devices used for comparison in this summary are: Epiphany Injector System (K090161) and MicroSTAAR™ Indigo Injector System (K073586). Intended Use The MicroSTAAR MSI Injector System is intended to fold and inse…
Staar Surgical Co.2009—
*K073586Microstaar Indigo Injector Foam Tip System
Summary page 1
…ystem Models: CQ, SFC 25, SFC 45 The primary devices used for comparison in this summary are: Epiphany Injector System (K090161) and MicroSTAAR™ Indigo Injector System (K073586). Intended Use The MicroSTAAR MSI Injector System is intended to fold and insert STAAR Surgical Company Collamer phakic and aph…
Staar Surgical Co.2008—
*K940593Disposable Microstaar Injector
Summary page 1
…the MicroSTAAR MSI Injector System. The intended use of the MSI Cartridges in this submission are substantially equivalent to the intended use of the predicate devices K940593 (CQ cartridge FP), K980696 (SFC-45 FP), and K073586 (SFC-25 FP). Please refer to Attachment 1 for a copy of the Directions for Us…
Staar Sugical19941
*K980696Foam Tip Injector
Summary page 1
…r System. The intended use of the MSI Cartridges in this submission are substantially equivalent to the intended use of the predicate devices K940593 (CQ cartridge FP), K980696 (SFC-45 FP), and K073586 (SFC-25 FP). Please refer to Attachment 1 for a copy of the Directions for Use for the predicate devices…
Staar Surgical Co.19981

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K172375MicroSTAAR Injector System CartridgesSTAAR Surgical Company20170
K152357MicroSTAAR Injector System CartridgesSTAAR Surgical Company20150

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 5.9 years on median.
  • 3 of the 10 ancestors have a recall of any class.
  • Of its descendants, K172375 (STAAR Surgical Company, 2017) has gone furthest, with 0 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. 2010, this device’s year, is highlighted.

FDA decisions per year · MSS

1in 2025

2007: 22008: 52009: 52010: 22011: 22012: 22013: 52014: 52015: 32016: 22017: 32018: 12019: 32020: 22021: 12023: 32024: 12025: 12026 (partial year): 1
2007high 5 (2008) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MSS

54in 2023

2008: 84 days median2009: 197 days median2013: 141 days median2014: 78 days median2015: 156 days median2017: 30 days median2019: 67 days median2023: 54 days median
2007high 197 (2009) · low 30 (2017)2026

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

Recalls per year · MSS

1in 2017

2016: 12017: 1
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

2007: 4452008: 1852009: 1862010: 2032011: 952012: 1292013: 2032014: 1142015: 1272016: 1122017: 1142018: 3402019: 2712020: 3622021: 2892022: 4902023: 3302024: 3752025: 429
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—0445
20085840185
200951970186
20102—0203
20112—095
20122—0129
201351410203
20145780114
201531560127
20162—1112
20173301114
20181—0340
20193670271
20202—0362
20211—0289
20220—0490
20233540330
20241—0375
20251—0429
20261—0—

What is it indicated for?

The MicroSTAAR™ MSI Injector System is a device intended to fold and insert STAAR™ Surgical Company Collamer phakic and aphakic one-piece and three-piece Collamer® intraocular lenses for surgical placement in the eye.

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

Recent decisions in MSS

The MSS category page

  • K261174RxSight® Insertion DeviceRxsight, Inc. · 2026
  • K252540ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AG · 2025
  • K242389EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, Incorporated · 2024
  • K231106Accuject Refra Injector AR2900Medicel AG · 2023
  • K231838RxSight® Insertion Device (63002)Rxsight, Inc. · 2023

https://510kreport.com/device/K101782 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101782: Microstaar Msi Injector System Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101782

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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