510(k) · Cleared
ClearedEyeGility™ Inserter for Preloaded enVista IOLs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Incorporated · MSS Folders And Injectors, Intraocular Lens (Iol)
Cleared on Oct 10, 2024 as substantially equivalent to K192005 (Bausch & Lomb, Inc., 2019) and 1 other predicate after a 59-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Oct 10, 2024
- Review
- 59 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K930320 (1994). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK930320 Amo Phacoflex Inserter, Foldable Iol Insert InstrAllergan Medical Optics · 1994
- 7 generations backK961242 Amo Phacoflex II Intersection SystemAllergan, Inc. · 1996
- 6 generations backK040837 Multiject Injector and Microglide CartridgeMedicel AG · 2004
- 5 generations backK070669 Iol Injector SetMedicel AG · 2007 · Recalled
- 4 generations backK092023 Naviject SUB2-1P, Model: LP604430Medicel AG · 2009
- 3 generations backK113852 Bausch & Lomb Iol InjectorBausch & Lomb, Inc. · 2012
- 2 generations backK131958 Bausch & Lomb Injector SystemBausch & Lomb · 2014
- 1 generation backK192005 Bausch + Lomb PreVue Inserter for enVista PreloadedBausch & Lomb, Inc. · 2019
- This deviceK242389 EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, Incorporated · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K930320 | Amo Phacoflex Inserter, Foldable Iol Insert Instr | Allergan Medical Optics | 1994 | — |
| −7 | K961242 | Amo Phacoflex II Intersection System | Allergan, Inc. | 1996 | — |
| −6 | K040837 | Multiject Injector and Microglide Cartridge | Medicel AG | 2004 | — |
| −5 | K070669 | Iol Injector Set | Medicel AG | 2007 | 1 |
| −4 | K092023 | Naviject SUB2-1P, Model: LP604430 | Medicel AG | 2009 | — |
| −3 | K113852 | Bausch & Lomb Iol Injector | Bausch & Lomb, Inc. | 2012 | — |
| −2 | K131958 | Bausch & Lomb Injector System | Bausch & Lomb | 2014 | — |
| −1 | K192005 | Bausch + Lomb PreVue Inserter for enVista Preloaded | Bausch & Lomb, Inc. | 2019 | — |
| 0 (this device) | K242389 | EyeGility™ Inserter for Preloaded enVista IOLs | Bausch & Lomb, Incorporated | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K192005 | Bausch + Lomb PreVue Inserter for enVista PreloadedSummary page 5…FDA Product Code: MSS Predicate Devices: Primary Predicate Device Bausch + Lomb PreVue Inserter for enVista Preloaded (K192005) Predicate Device Bausch + Lomb IOL Injector, INJ 100 (K113852) Devi… | 2019 |
| * | K113852 | Bausch & Lomb Iol InjectorSummary page 5…h + Lomb PreVue Inserter for enVista Preloaded (K192005) Predicate Device Bausch + Lomb IOL Injector, INJ 100 (K113852) Device Description: The EyeGility Inserter is a sterile, single-use device used to fold and… | 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 30 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- 3 of the 12 ancestors have a recall of any class.
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. 2024, 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 EyeGility Inserter for enVista preloaded is indicated for folding and inserting of enVista IOL models approved for use with this IOL insertion device as indicated in the IOL approved labeling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242389 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242389: EyeGility™ Inserter for Preloaded enVista IOLs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242389
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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