510(k) · Cleared
ClearedMonarch Iii Iol Delivery System; Monarch Iii P Catridge; Monarch Iii Handpiece (H4)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Manufacturing, Ltd. · MSS Folders And Injectors, Intraocular Lens (Iol)
Cleared on Oct 13, 2011 as substantially equivalent to K063155 (Alcon Manufacturing, Ltd., 2007) after a 476-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Oct 13, 2011
- Review
- 476 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001157 (2000). 3 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK101774 Monarch Iii Iol Delivery System; Monarch Iii P Catridge; Monarch Iii…Alcon Manufacturing, Ltd. · 2011
View 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) | K101774 | Monarch Iii Iol Delivery System; Monarch Iii P Catridge; Monarch Iii Handpiece… | Alcon Manufacturing, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (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 | Decided |
|---|---|---|---|
| * | K063155 | Monarch Iii Iol Delivery SystemSummary page 1…Name: 21 CFR 886.4300 1. Predicate Devices: The legally marketed device(s) to which we are claiming substantial equivalence are: 51()Number Device K063 155 Monarch® III JOL Delivery System (D Cartridge) 2. Device Description: The Monarch® III JOL Delivery System (P C… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 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.
- 6 other devices also cite its predicate K063155.
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. 2011, 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 P 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/K101774 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101774: Monarch Iii Iol Delivery System; Monarch Iii P Catridge; Monarch Iii Handpiece (H4).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101774
Report an extraction error
Are you the manufacturer?
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