510(k) · Cleared
ClearedInjector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anton Meyer & Co., Ltd. · MSS Folders And Injectors, Intraocular Lens (Iol)
Cleared on Jul 14, 2003 as substantially equivalent to K011392 (Micra Instruments, 2001) and 3 other predicates after a 249-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Jul 14, 2003
- Review
- 249 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K930320 (1994). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK930320 Amo Phacoflex Inserter, Foldable Iol Insert InstrAllergan Medical Optics · 1994
- 1 generation backK961242 Amo Phacoflex II Intersection SystemAllergan, Inc. · 1996
- This deviceK023737 InjectorAnton Meyer & Co., Ltd. · 2003
- Descendant · cites it directly · 0 of its ownK073010 Royale AE 9036 LSP InjectorAsico, LLC · 2007
Most influential descendants
Showing 1 of 1 · See all- K073010Royale AE 9036 LSP InjectorAsico, LLC · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930320 | Amo Phacoflex Inserter, Foldable Iol Insert Instr | Allergan Medical Optics | 1994 | — |
| −1 | K961242 | Amo Phacoflex II Intersection System | Allergan, Inc. | 1996 | — |
| 0 (this device) | K023737 | Injector | Anton Meyer & Co., Ltd. | 2003 | — |
| +1 | K073010 | Royale AE 9036 LSP Injector | Asico, LLC | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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? (4)
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 |
|---|---|---|---|
| * | K011392 | Micra Lens Injector, Micra Cartridge Lens, Micra Lens LoaderSummary page 2…FR 886.4300 1. Predicate Device: The predicate devices to which we are claiming equivalence are: a) Hand piece of Micra lnstument Ltd. Lens Insertion System K 01 1392 b) Hand piece of MONARCH@II IOL; K 003768 c) Hand piece of Micro STAARTMInjector; K983129 d) Hand piece of AM0 Phacophle… | 2001 |
| * | K003768 | Monarch II Iol Delivery SystemSummary page 2…predicate devices to which we are claiming equivalence are: a) Hand piece of Micra lnstument Ltd. Lens Insertion System K 01 1392 b) Hand piece of MONARCH@II IOL; K 003768 c) Hand piece of Micro STAARTMInjector; K983129 d) Hand piece of AM0 Phacophlex II; K961242 2. Device Description… | 2001 |
| * | K983129 | Disposable Microstaar Injector (Model Msi-P1)Summary page 2…nce are: a) Hand piece of Micra lnstument Ltd. Lens Insertion System K 01 1392 b) Hand piece of MONARCH@II IOL; K 003768 c) Hand piece of Micro STAARTMInjector; K983129 d) Hand piece of AM0 Phacophlex II; K961242 2. Device Description The injector is an autoclavable, reusable titaniu… | 1998 |
| * | K961242 | Amo Phacoflex II Intersection SystemSummary page 2…d. Lens Insertion System K 01 1392 b) Hand piece of MONARCH@II IOL; K 003768 c) Hand piece of Micro STAARTMInjector; K983129 d) Hand piece of AM0 Phacophlex II; K961242 2. Device Description The injector is an autoclavable, reusable titanium hand piece which is used to deliver folded… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K073010 (Asico, LLC, 2007) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K011392.
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 | — |
What is it indicated for?
The Royale®AE 9045 injector is intended as a reusable instrument to assist in implanting Alcon ACRYSOF® foldable intraocular lenses during a normal small incision cataract surgery. It is designed to incorporate Alcon cartridges Type C for foldable intraocular lenses. The cartridge is loaded into the injector body and by pushing the piston. The lens will be removed out of the cartridge and delivered to the desired position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023737 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023737: Injector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023737
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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