510(k) · Cleared
ClearedEasy-Load Lens Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch and Lomb, Inc., · MSS Folders And Injectors, Intraocular Lens (Iol)
Cleared on Jul 6, 2016 as substantially equivalent to K132481 (Bausch & Lomb, 2013) and 1 other predicate after an 86-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Jul 6, 2016
- Review
- 86 days
- Class
- Class I
- Product code
- MSS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K930320 (1994). 14 ancestors in all, the oldest K914311 (1992). No later device cites it as a predicate yet.
- 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 deviceK161012 Easy-Load Lens Delivery SystemBausch and Lomb, Inc., · 2016
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) | K161012 | Easy-Load Lens Delivery System | Bausch and Lomb, Inc., | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K132481 | Easy-Load Lens Delivery SystemSummary page 4…asy-Load Lens Delivery System Common Name: Intraocular lens Guide Classification Name: 21 CFR 886.4300 2. Predicate Device: Primary Predicate Device K132481 Easy-Load Lens Delivery System EZ-28 Secondary Predicate Device K131958 Bausch + Lomb Injector System BLIS-X1 3. Device Des… | 2013 |
| * | K131958 | Bausch & Lomb Injector SystemSummary page 4…uide Classification Name: 21 CFR 886.4300 2. Predicate Device: Primary Predicate Device K132481 Easy-Load Lens Delivery System EZ-28 Secondary Predicate Device K131958 Bausch + Lomb Injector System BLIS-X1 3. Device Description: The Easy-Load Lens Delivery System is used for folding and del… | 2014 |
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 22 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 4 of the 14 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. 2016, 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 Easy-Load Lens Delivery System is indicated for the folding and injection of
Bausch + Lomb intraocular lenses identifying the Easy-Load Lens Delivery
System in their approved labeling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161012: Easy-Load Lens 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/K161012
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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