510(k) · Cleared
ClearedMonarch II Iol Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Research, Ltd. · MSS Folders And Injectors, Intraocular Lens (Iol)
Cleared on Jan 5, 2001 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 45 later devices descend from it.
- Decided
- Jan 5, 2001
- Review
- 30 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 0
45 later devices descend from it, 6 citing it directly.
- This deviceK003768 Monarch II Iol Delivery SystemAlcon Research, Ltd. · 2001
- Descendant · cites it directly · 28 of its ownK063155 Monarch Iii Iol Delivery SystemAlcon Manufacturing, Ltd. · 2007 · Recalled
- Descendant · cites it directly · 25 of its ownK040837 Multiject Injector and Microglide CartridgeMedicel AG · 2004
- Descendant · 2 generations on · 19 of its ownK070669 Iol Injector SetMedicel AG · 2007 · Recalled
- Descendant · 3 generations on · 18 of its ownK092023 Naviject SUB2-1P, Model: LP604430Medicel AG · 2009
- Descendant · 2 generations on · 12 of its ownK113852 Bausch & Lomb Iol InjectorBausch & Lomb, Inc. · 2012
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K063155Monarch Iii Iol Delivery SystemAlcon Manufacturing, Ltd. · 2007 · cites it directly28descendants
- K040837Multiject Injector and Microglide CartridgeMedicel AG · 2004 · cites it directly25descendants
- K070669Iol Injector SetMedicel AG · 2007 · 2 generations on19descendants
- K092023Naviject SUB2-1P, Model: LP604430Medicel AG · 2009 · 3 generations on18descendants
- K113852Bausch & Lomb Iol InjectorBausch & Lomb, Inc. · 2012 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003768 | Monarch II Iol Delivery System | Alcon Research, Ltd. | 2001 | — |
| +1 | K063155 | Monarch Iii Iol Delivery System | Alcon Manufacturing, Ltd. | 2007 | 1 |
| +1 | K040837 | Multiject Injector and Microglide Cartridge | Medicel AG | 2004 | — |
| +2 | K070669 | Iol Injector Set | Medicel AG | 2007 | 1 |
| +3 | K092023 | Naviject SUB2-1P, Model: LP604430 | Medicel AG | 2009 | — |
| +2 | K113852 | Bausch & Lomb Iol Injector | Bausch & Lomb, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (45)
See all 456 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063155 | Monarch Iii Iol Delivery System | 2007 | 28 |
| K040837 | Multiject Injector and Microglide Cartridge | 2004 | 25 |
| K112977 | Monarch Iii Iol Delivery System, Monarch Iii C Cartridge, Monarch Iii Handpiece (H4) | 2012 | 2 |
| K023737 | Injector | 2003 | 1 |
| K082871 | Xact Lens Inserter System, Models 6MM, 7MM | 2009 | 0 |
| K073010 | Royale AE 9036 LSP Injector | 2007 | 0 |
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?
- Of its descendants, K063155 (Alcon Manufacturing, Ltd., 2007) has gone furthest, with 28 descendants of its own.
How does its category compare?
All MSS devicesMSS 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
2026 to Oct 25, outlined.
Median 510(k) review, days · MSS
54in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSS
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSS
429in 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 | — |
https://510kreport.com/device/K003768 · printed Nov 5, 2026
Cite this page
510(k) Report. “K003768: Monarch II Iol Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003768
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026