510(k) · Cleared
ClearedBausch + Lomb PreVue Inserter for enVista Preloaded
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Inc. · MSS Folders And Injectors, Intraocular Lens (Iol)
Cleared on Oct 4, 2019 as substantially equivalent to K113852 (Bausch & Lomb, Inc., 2012) and 1 other predicate after a 67-day review. Its family tree reaches back 7 generations to 1994. 1 later device descends from it.
- Decided
- Oct 4, 2019
- Review
- 67 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K930320 (1994). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK930320 Amo Phacoflex Inserter, Foldable Iol Insert InstrAllergan Medical Optics · 1994
- 6 generations backK961242 Amo Phacoflex II Intersection SystemAllergan, Inc. · 1996
- 5 generations backK040837 Multiject Injector and Microglide CartridgeMedicel AG · 2004
- 4 generations backK070669 Iol Injector SetMedicel AG · 2007 · Recalled
- 3 generations backK092023 Naviject SUB2-1P, Model: LP604430Medicel AG · 2009
- 2 generations backK113852 Bausch & Lomb Iol InjectorBausch & Lomb, Inc. · 2012
- 1 generation backK131958 Bausch & Lomb Injector SystemBausch & Lomb · 2014
- This deviceK192005 Bausch + Lomb PreVue Inserter for enVista PreloadedBausch & Lomb, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK242389 EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, Incorporated · 2024
Most influential descendants
Showing 1 of 1 · See all- K242389EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, Incorporated · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930320 | Amo Phacoflex Inserter, Foldable Iol Insert Instr | Allergan Medical Optics | 1994 | — |
| −6 | K961242 | Amo Phacoflex II Intersection System | Allergan, Inc. | 1996 | — |
| −5 | K040837 | Multiject Injector and Microglide Cartridge | Medicel AG | 2004 | — |
| −4 | K070669 | Iol Injector Set | Medicel AG | 2007 | 1 |
| −3 | K092023 | Naviject SUB2-1P, Model: LP604430 | Medicel AG | 2009 | — |
| −2 | K113852 | Bausch & Lomb Iol Injector | Bausch & Lomb, Inc. | 2012 | — |
| −1 | K131958 | Bausch & Lomb Injector System | Bausch & Lomb | 2014 | — |
| 0 (this device) | K192005 | Bausch + Lomb PreVue Inserter for enVista Preloaded | Bausch & Lomb, Inc. | 2019 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K113852 | Bausch & Lomb Iol InjectorSummary page 4…Classification Name: Intraocular lens guide (21 CFR 886.4300) FDA Product Code: MSS Predicate Devices: 1. Bausch & Lomb Injector System (K113852) 2. Bausch & Lomb Injector System, BLIS (K131958) Device Description: The Bausch + Lomb Pr… | 2012 |
| * | K131958 | Bausch & Lomb Injector SystemSummary page 4…roduct Code: MSS Predicate Devices: 1. Bausch & Lomb Injector System (K113852) 2. Bausch & Lomb Injector System, BLIS (K131958) Device Description: The Bausch + Lomb PreVue inserter for enVista preloaded is a sterile,… | 2014 |
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 |
|---|---|---|---|
| K242389 | EyeGility™ Inserter for Preloaded enVista IOLs | 2024 | 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 25 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K242389 (Bausch & Lomb, Incorporated, 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K113852.
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. 2019, 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 Bausch + Lomb PreVue inserter for enVista preloaded is indicated for folding and inserting of enVista IOLs (Model MX60PL) and 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/K192005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192005: Bausch + Lomb PreVue Inserter for enVista Preloaded.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192005
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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