510(k) · Cleared
Recalled · Class II · 2024Monarch Iii Iol Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Manufacturing, Ltd. · KYB Lens, Guide, Intraocular
Cleared on Mar 27, 2007 as substantially equivalent to K003768 (Alcon Research, Ltd., 2001) and 1 other predicate after a 161-day review. Its family tree reaches back 1 generation to 2000. 28 later devices descend from it. It has been recalled once.
- Decided
- Mar 27, 2007
- Review
- 161 days
- Class
- Class I
- Product code
- KYB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K001157 (2000). 2 ancestors in all. 28 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK001157 Monarch II Iol Delivery SystemAlcon Research, Ltd. · 2000 · Recalled
- This deviceK063155 Monarch Iii Iol Delivery SystemAlcon Manufacturing, Ltd. · 2007
- Descendant · cites it directly · 12 of its ownK113852 Bausch & Lomb Iol InjectorBausch & Lomb, Inc. · 2012
- Descendant · cites it directly · 9 of its ownK131958 Bausch & Lomb Injector SystemBausch & Lomb · 2014
- Descendant · cites it directly · 8 of its ownK112425 Infiniti Vision System Evergreen II Autosert Iol Injector HandpieceAlcon Manufacturing, Ltd. · 2011
- Descendant · 2 generations on · 6 of its ownK121555 Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 5 of its ownK151102 Bausch + Lomb Injector SystemBausch & Lomb, Inc. · 2015
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K113852Bausch & Lomb Iol InjectorBausch & Lomb, Inc. · 2012 · cites it directly12descendants
- K131958Bausch & Lomb Injector SystemBausch & Lomb · 2014 · cites it directly9descendants
- K112425Infiniti Vision System Evergreen II Autosert Iol Injector HandpieceAlcon Manufacturing, Ltd. · 2011 · cites it directly8descendants
- K121555Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · 2 generations on6descendants
- K151102Bausch + Lomb Injector SystemBausch & Lomb, Inc. · 2015 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001157 | Monarch II Iol Delivery System | Alcon Research, Ltd. | 2000 | 1 |
| 0 (this device) | K063155 | Monarch Iii Iol Delivery System | Alcon Manufacturing, Ltd. | 2007 | — |
| +1 | K113852 | Bausch & Lomb Iol Injector | Bausch & Lomb, Inc. | 2012 | — |
| +1 | K131958 | Bausch & Lomb Injector System | Bausch & Lomb | 2014 | — |
| +1 | K112425 | Infiniti Vision System Evergreen II Autosert Iol Injector Handpiece | Alcon Manufacturing, Ltd. | 2011 | — |
| +2 | K121555 | Centurion Vision System | Alcon Laboratories, Inc. | 2012 | 4 |
| +2 | K151102 | Bausch + Lomb Injector System | Bausch & Lomb, Inc. | 2015 | — |
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 |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 KYB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K003768 | Monarch II 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: 510(k) Number Device K003768 Monarch® II IOL Delivery System (A & C Cartridges) K001 157 Monarch® II IOL Delivery System (B Car… | 2001 |
| * | K001157 | Monarch II Iol Delivery SystemSummary page 1…vice(s) to which we are claiming substantial equivalence are: 510(k) Number Device K003768 Monarch® II IOL Delivery System (A & C Cartridges) K001 157 Monarch® II IOL Delivery System (B Cartridge) 2. Device Description: The Monarch©D III LOL Delivery System is… | 2000 |
What descends from it? (28)
See all 287 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113852 | Bausch & Lomb Iol Injector | 2012 | 12 |
| K131958 | Bausch & Lomb Injector System | 2014 | 9 |
| K112425 | Infiniti Vision System Evergreen II Autosert Iol Injector Handpiece | 2011 | 8 |
| K120912 | Infiniti (R) Vision System | 2012 | 3 |
| K112977 | Monarch Iii Iol Delivery System, Monarch Iii C Cartridge, Monarch Iii Handpiece (H4) | 2012 | 2 |
| K182965 | BL-Cart IOL Delivery Cartridge | 2019 | 1 |
| K101774 | Monarch Iii Iol Delivery System; Monarch Iii P Catridge; Monarch Iii Handpiece (H4) | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 13, 2024 | Class II | Z-0835-2025 | Process design | Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (IOL) upon delivery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KYB devicesKYB Lens, Guide, Intraocular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · KYB
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KYB
161in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KYB
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KYB
389in 2025
MAUDE reports naming product code KYB, 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 | 3 | 161 | 0 | 570 |
| 2008 | 2 | — | 1 | 258 |
| 2009 | 0 | — | 1 | 73 |
| 2010 | 0 | — | 0 | 81 |
| 2011 | 0 | — | 0 | 58 |
| 2012 | 0 | — | 0 | 125 |
| 2013 | 0 | — | 0 | 39 |
| 2014 | 0 | — | 0 | 49 |
| 2015 | 1 | — | 0 | 160 |
| 2016 | 0 | — | 0 | 256 |
| 2017 | 0 | — | 0 | 335 |
| 2018 | 0 | — | 0 | 592 |
| 2019 | 0 | — | 0 | 703 |
| 2020 | 0 | — | 0 | 335 |
| 2021 | 0 | — | 0 | 349 |
| 2022 | 0 | — | 0 | 294 |
| 2023 | 0 | — | 0 | 304 |
| 2024 | 0 | — | 1 | 393 |
| 2025 | 0 | — | 0 | 389 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MONARCH® III IOL Delivery System is used for implantation of ALCON® qualified ACRYSOF® intraocular lenses into the eye following cataract removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063155: Monarch Iii Iol Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063155
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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