510(k) · Cleared
ClearedCeeon Easysert Intraocular Lens Injector, Model Imp-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmacia & Upjohn Co. · MSS Folders And Injectors, Intraocular Lens (Iol)
Cleared on Oct 31, 2000 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Oct 31, 2000
- Review
- 75 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK002556 Ceeon Easysert Intraocular Lens Injector, Model Imp-1Pharmacia & Upjohn Co. · 2000
- Descendant · cites it directly · 3 of its ownK090161 Epiphany Injection SystemStaar Surgical Co. · 2009
- Descendant · 2 generations on · 2 of its ownK101782 Microstaar Msi Injector System CartridgeStaar Japan · 2010
- Descendant · 3 generations on · 0 of its ownK172375 MicroSTAAR Injector System CartridgesSTAAR Surgical Company · 2017
- Descendant · 3 generations on · 0 of its ownK152357 MicroSTAAR Injector System CartridgesSTAAR Surgical Company · 2015
- Descendant · cites it directly · 0 of its ownK082871 Xact Lens Inserter System, Models 6MM, 7MMSis Ltd., Surgical Instrument Systems · 2009
Most influential descendants
Showing 5 of 5 · See all- K090161Epiphany Injection SystemStaar Surgical Co. · 2009 · cites it directly3descendants
- K101782Microstaar Msi Injector System CartridgeStaar Japan · 2010 · 2 generations on2descendants
- K172375MicroSTAAR Injector System CartridgesSTAAR Surgical Company · 2017 · 3 generations on0descendants
- K152357MicroSTAAR Injector System CartridgesSTAAR Surgical Company · 2015 · 3 generations on0descendants
- K082871Xact Lens Inserter System, Models 6MM, 7MMSis Ltd., Surgical Instrument Systems · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002556 | Ceeon Easysert Intraocular Lens Injector, Model Imp-1 | Pharmacia & Upjohn Co. | 2000 | — |
| +1 | K090161 | Epiphany Injection System | Staar Surgical Co. | 2009 | — |
| +2 | K101782 | Microstaar Msi Injector System Cartridge | Staar Japan | 2010 | — |
| +3 | K172375 | MicroSTAAR Injector System Cartridges | STAAR Surgical Company | 2017 | — |
| +3 | K152357 | MicroSTAAR Injector System Cartridges | STAAR Surgical Company | 2015 | — |
| +1 | K082871 | Xact Lens Inserter System, Models 6MM, 7MM | Sis Ltd., Surgical Instrument Systems | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K090161 (Staar Surgical Co., 2009) has gone furthest, with 3 descendants of its own.
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 | — |
https://510kreport.com/device/K002556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002556: Ceeon Easysert Intraocular Lens Injector, Model Imp-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002556
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026