510(k) · Cleared
Recalled · Class II · 2016Monarch Iii Iol Delivery System, Monarch Iii C Cartridge, Monarch Iii Handpiece (H4)
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 Mar 27, 2012 as substantially equivalent to K001157 (Alcon Research, Ltd., 2000) and 2 other predicates after a 173-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it. It has been recalled once.
- Decided
- Mar 27, 2012
- Review
- 173 days
- Class
- Class I
- Product code
- MSS
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K001157 (2000). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK001157 Monarch II Iol Delivery SystemAlcon Research, Ltd. · 2000 · Recalled
- 1 generation backK063155 Monarch Iii Iol Delivery SystemAlcon Manufacturing, Ltd. · 2007 · Recalled
- This deviceK112977 Monarch Iii Iol Delivery System, Monarch Iii C Cartridge, Monarch…Alcon Research, Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK212039 CLAREON MONARCH IV IOL Delivery SystemAlcon Laboratories, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK123888 Z Cartridge Iol Delivery SystemAaren Scientific, Inc. · 2013 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001157 | Monarch II Iol Delivery System | Alcon Research, Ltd. | 2000 | 1 |
| −1 | K063155 | Monarch Iii Iol Delivery System | Alcon Manufacturing, Ltd. | 2007 | 1 |
| 0 (this device) | K112977 | Monarch Iii Iol Delivery System, Monarch Iii C Cartridge, Monarch Iii… | Alcon Research, Ltd. | 2012 | — |
| +1 | K212039 | CLAREON MONARCH IV IOL Delivery System | Alcon Laboratories, Inc. | 2021 | — |
| +1 | K123888 | Z Cartridge Iol Delivery System | Aaren Scientific, Inc. | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
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
- #3 Held for the reportin the report
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K001157 | Monarch II Iol Delivery System | 2000 |
| * | K003768 | Monarch II Iol Delivery SystemSummary page 2…_ _ _ _ _ _ _ _ _ _ _ _ _ ______ ______ ______Cartridge) 510(k) Number K112977 K003768 K063155 Substantial Equivalenc Characteristics Intended U… | 2001 |
| * | K063155 | Monarch Iii Iol Delivery SystemSummary page 1…evice(s) to which we are claiming substantial equivalence are: 510(k) Number Device KOOl 157 Monarch® 11 (C Cartridge) TOL Delivery System K063 155 Monarch mI (D Cartridge) JOL Delivery System 2. Device Description: The Monarch® III IOL Delivery System (C Ca… | 2007 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 5, 2016 | Class II | Z-0978-2017 | Device Design | The intraocular lens could become lodged within the cartridge |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 6.7 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K212039 (Alcon Laboratories, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K001157.
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. 2012, this device’s year, is highlighted.
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 | — |
What is it indicated for?
This Monarch® III C Cartridge IOL insertion device is indicated to fold/hold and insert Alcon IOLs that have the use of this inserter in their approved labeling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112977 · printed Nov 5, 2026
Cite this page
510(k) Report. “K112977: Monarch Iii Iol Delivery System, Monarch Iii C Cartridge, Monarch Iii Handpiece (H4).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K112977
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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