510(k) · Cleared
ClearedAmo Phacoflex II Intersection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allergan, Inc. · KYB Lens, Guide, Intraocular
Cleared on Jun 17, 1996 as substantially equivalent to K941603 (Allergan Medical Optics, 1994) and 1 other predicate after a 77-day review. Its family tree reaches back 1 generation to 1994. 31 later devices descend from it.
- Decided
- Jun 17, 1996
- Review
- 77 days
- Class
- Class I
- Product code
- KYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K930320 (1994). 2 ancestors in all. 31 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK930320 Amo Phacoflex Inserter, Foldable Iol Insert InstrAllergan Medical Optics · 1994
- This deviceK961242 Amo Phacoflex II Intersection SystemAllergan, Inc. · 1996
- Descendant · cites it directly · 25 of its ownK040837 Multiject Injector and Microglide CartridgeMedicel AG · 2004
- Descendant · 2 generations on · 19 of its ownK070669 Iol Injector SetMedicel AG · 2007 · Recalled
- Descendant · 3 generations on · 18 of its ownK092023 Naviject SUB2-1P, Model: LP604430Medicel AG · 2009
- Descendant · 4 generations on · 12 of its ownK113852 Bausch & Lomb Iol InjectorBausch & Lomb, Inc. · 2012
- Descendant · 2 generations on · 12 of its ownK050638 Lenstec Intraocular Lens (Iol) Injection System for Tetraflex…Lenstec, Inc. · 2005
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K040837Multiject Injector and Microglide CartridgeMedicel AG · 2004 · cites it directly25descendants
- K070669Iol Injector SetMedicel AG · 2007 · 2 generations on19descendants
- K092023Naviject SUB2-1P, Model: LP604430Medicel AG · 2009 · 3 generations on18descendants
- K113852Bausch & Lomb Iol InjectorBausch & Lomb, Inc. · 2012 · 4 generations on12descendants
- K050638Lenstec Intraocular Lens (Iol) Injection System for Tetraflex Intraocular LensesLenstec, Inc. · 2005 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930320 | Amo Phacoflex Inserter, Foldable Iol Insert Instr | Allergan Medical Optics | 1994 | — |
| 0 (this device) | K961242 | Amo Phacoflex II Intersection System | Allergan, Inc. | 1996 | — |
| +1 | K040837 | Multiject Injector and Microglide Cartridge | Medicel AG | 2004 | — |
| +2 | K070669 | Iol Injector Set | Medicel AG | 2007 | 1 |
| +3 | K092023 | Naviject SUB2-1P, Model: LP604430 | Medicel AG | 2009 | — |
| +4 | K113852 | Bausch & Lomb Iol Injector | Bausch & Lomb, Inc. | 2012 | — |
| +2 | K050638 | Lenstec Intraocular Lens (Iol) Injection System for Tetraflex Intraocular Lenses | Lenstec, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 KYB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K941603 | Amo Phacoflex Inserter Disposable Cartridge, and HandpieceSummary page 1…de Classification name: intraocular lens guide 3. Identification of the predicate device or legally marketed device to which substantial equivalence is claimed: 510(k) K941603, cleared on 7/6/94, filed by Allergan Medical Optics, AMO®PhacoFlex® Inserter Disposable Cartridge 510(k) K930320, cleared on 4/… | 1994 |
| * | K930320 | Amo Phacoflex Inserter, Foldable Iol Insert InstrSummary page 1…e to which substantial equivalence is claimed: 510(k) K941603, cleared on 7/6/94, filed by Allergan Medical Optics, AMO®PhacoFlex® Inserter Disposable Cartridge 510(k) K930320, cleared on 4/7/94, filed by Allergan Medical Optics, AMO®PhacoFlex® Inserter Allergan, Inc. - Strictly Private… | 1994 |
What descends from it? (31)
See all 314 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K040837 (Medicel AG, 2004) has gone furthest, with 25 descendants of its own.
How does its category compare?
All KYB devicesKYB Lens, Guide, Intraocular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KYB
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KYB
161in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KYB
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KYB
389in 2025
MAUDE reports naming product code KYB, 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 | 3 | 161 | 0 | 570 |
| 2008 | 2 | — | 1 | 258 |
| 2009 | 0 | — | 1 | 73 |
| 2010 | 0 | — | 0 | 81 |
| 2011 | 0 | — | 0 | 58 |
| 2012 | 0 | — | 0 | 125 |
| 2013 | 0 | — | 0 | 39 |
| 2014 | 0 | — | 0 | 49 |
| 2015 | 1 | — | 0 | 160 |
| 2016 | 0 | — | 0 | 256 |
| 2017 | 0 | — | 0 | 335 |
| 2018 | 0 | — | 0 | 592 |
| 2019 | 0 | — | 0 | 703 |
| 2020 | 0 | — | 0 | 335 |
| 2021 | 0 | — | 0 | 349 |
| 2022 | 0 | — | 0 | 294 |
| 2023 | 0 | — | 0 | 304 |
| 2024 | 0 | — | 1 | 393 |
| 2025 | 0 | — | 0 | 389 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AMO®PhacoFlex® II Insertion System is used to fold and assist in inserting the AMO®PhacoFlex® II (SLM-2/UV) family of intraocular lenses, specifically the SI-30NB and SI-40NB, into the eye.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961242 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961242: Amo Phacoflex II Intersection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961242
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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