510(k) · Cleared
ClearedCLAREON MONARCH IV IOL Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories, Inc. · MSS Folders And Injectors, Intraocular Lens (Iol)
Cleared on Aug 23, 2021 as substantially equivalent to K112977 (Alcon Research, Ltd., 2012) after a 54-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Aug 23, 2021
- Review
- 54 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001157 (2000). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK001157 Monarch II Iol Delivery SystemAlcon Research, Ltd. · 2000 · Recalled
- 2 generations backK063155 Monarch Iii Iol Delivery SystemAlcon Manufacturing, Ltd. · 2007 · Recalled
- 1 generation backK112977 Monarch Iii Iol Delivery System, Monarch Iii C Cartridge, Monarch…Alcon Research, Ltd. · 2012 · Recalled
- This deviceK212039 CLAREON MONARCH IV IOL Delivery SystemAlcon Laboratories, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001157 | Monarch II Iol Delivery System | Alcon Research, Ltd. | 2000 | 1 |
| −2 | K063155 | Monarch Iii Iol Delivery System | Alcon Manufacturing, Ltd. | 2007 | 1 |
| −1 | K112977 | Monarch Iii Iol Delivery System, Monarch Iii C Cartridge, Monarch Iii… | Alcon Research, Ltd. | 2012 | 1 |
| 0 (this device) | K212039 | CLAREON MONARCH IV IOL Delivery System | Alcon Laboratories, Inc. | 2021 | — |
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 |
|---|---|---|---|
| * | K112977 | Monarch Iii Iol Delivery System, Monarch Iii C Cartridge, Monarch Iii Handpiece (H4)Summary page 4…de Names: Monarch III IOL Delivery System, Monarch III C cartridge, Monarch III Handpiece (H4) 510K Number K112977 FDA Clearance date 03/27/2012 Submitter Alcon Laboratories, Inc. Common Name:… | 2012 |
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 21 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- 3 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K112977.
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. 2021, 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?
The CLAREON MONARCH IV IOL Delivery System is for implantation of qualified Alcon foldable IOLs. No unqualified lenses should be used with the CLAREON MONARCH IV IOL Delivery System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212039 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212039: CLAREON MONARCH IV 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/K212039
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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