510(k) · Cleared
ClearedInfiniti Vision System Evergreen II Autosert Iol Injector Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Manufacturing, Ltd. · HQC Unit, Phacofragmentation
Cleared on Nov 21, 2011 as substantially equivalent to K021566 (Alcon Laboratories, Inc., 2002) and 4 other predicates after a 90-day review. Its family tree reaches back 5 generations to 1985. 8 later devices descend from it.
- Decided
- Nov 21, 2011
- Review
- 90 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K844373 (1985). 28 ancestors in all, the oldest K842458 (1984). 8 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK844373 O.M.S. Ultra-PhacoOptical Micro Systems, Inc. · 1985
- 4 generations backK981116 Sovereign Cataract Extraction SystemAllergan, Inc. · 1998 · Recalled
- 3 generations backK021566 InfinitiAlcon Laboratories, Inc. · 2002 · Recalled
- 2 generations backK063583 Alcon Vision SystemAlcon · 2008 · Recalled
- 1 generation backK082845 Infiniti Vision System with Ozil IPAlcon Research, Ltd. · 2009
- This deviceK112425 Infiniti Vision System Evergreen II Autosert Iol Injector HandpieceAlcon Manufacturing, Ltd. · 2011
- Descendant · cites it directly · 6 of its ownK121555 Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 3 of its ownK161794 CENTURION Vision System (Active SentryTM)Alcon Research, Ltd. · 2017
- Descendant · cites it directly · 3 of its ownK120912 Infiniti (R) Vision SystemAlcon Manufacturing, Ltd. · 2012 · Recalled
- Descendant · cites it directly · 2 of its ownK141065 Constellation Vision SystemAlcon Research, Ltd. · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK233876 Unity VCS (8065000296); Unity CS (8065000297)Alcon Laboratories, Inc. · 2024 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K121555Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · cites it directly6descendants
- K161794CENTURION Vision System (Active SentryTM)Alcon Research, Ltd. · 2017 · 2 generations on3descendants
- K120912Infiniti (R) Vision SystemAlcon Manufacturing, Ltd. · 2012 · cites it directly3descendants
- K141065Constellation Vision SystemAlcon Research, Ltd. · 2014 · cites it directly2descendants
- K233876Unity VCS (8065000296); Unity CS (8065000297)Alcon Laboratories, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K844373 | O.M.S. Ultra-Phaco | Optical Micro Systems, Inc. | 1985 | — |
| −4 | K981116 | Sovereign Cataract Extraction System | Allergan, Inc. | 1998 | 1 |
| −3 | K021566 | Infiniti | Alcon Laboratories, Inc. | 2002 | 3 |
| −2 | K063583 | Alcon Vision System | Alcon | 2008 | 11 |
| −1 | K082845 | Infiniti Vision System with Ozil IP | Alcon Research, Ltd. | 2009 | — |
| 0 (this device) | K112425 | Infiniti Vision System Evergreen II Autosert Iol Injector Handpiece | Alcon Manufacturing, Ltd. | 2011 | — |
| +1 | K121555 | Centurion Vision System | Alcon Laboratories, Inc. | 2012 | 4 |
| +2 | K161794 | CENTURION Vision System (Active SentryTM) | Alcon Research, Ltd. | 2017 | — |
| +1 | K120912 | Infiniti (R) Vision System | Alcon Manufacturing, Ltd. | 2012 | 1 |
| +1 | K141065 | Constellation Vision System | Alcon Research, Ltd. | 2014 | 6 |
| +2 | K233876 | Unity VCS (8065000296); Unity CS (8065000297) | Alcon Laboratories, Inc. | 2024 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 4 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 2 | 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 HQC? 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 HQC device
- #1 K261264 Stellaris Elite™ vision enhancement system…score 13.4 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K021566 | InfinitiSummary page 1…886.4670) Predicate Devices: The legally marketed devices(s) to which we are claiming equivalence to are: 510(k) Number Device K021566 Infiniti® Vision System K082845 Infiniti® Vision System with OZil® IP K091777… | 2002 |
| * | K082845 | Infiniti Vision System with Ozil IPSummary page 1…legally marketed devices(s) to which we are claiming equivalence to are: 510(k) Number Device K021566 Infiniti® Vision System K082845 Infiniti® Vision System with OZil® IP K091777 Alcon UltraChopper Tip K093210… | 2009 |
| * | K091777 | Alcon UltrachopperSummary page 1…are: 510(k) Number Device K021566 Infiniti® Vision System K082845 Infiniti® Vision System with OZil® IP K091777 Alcon UltraChopper Tip K093210 AquaL-ase Capsule Wash Tip K063155 Monarc… | 2009 |
| * | K093210 | Aqualase Capsule Wash TipSummary page 1…21566 Infiniti® Vision System K082845 Infiniti® Vision System with OZil® IP K091777 Alcon UltraChopper Tip K093210 AquaL-ase Capsule Wash Tip K063155 Monarch IIl IOL Delivery System Device Description… | 2010 |
| * | K063155 | Monarch Iii Iol Delivery SystemSummary page 1…45 Infiniti® Vision System with OZil® IP K091777 Alcon UltraChopper Tip K093210 AquaL-ase Capsule Wash Tip K063155 Monarch IIl IOL Delivery System Device Description The Infinitio Vision System is an enhanced version of t… | 2007 |
What descends from it? (8)
3 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?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
- 10 of the 28 ancestors have a recall of any class.
- Of its descendants, K121555 (Alcon Laboratories, Inc., 2012) has gone furthest, with 6 descendants of its own.
- 9 other devices also cite its predicate K021566.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HQC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQC
1,799in 2025
MAUDE reports naming product code HQC, 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 | 0 | — | 0 | 341 |
| 2008 | 4 | 162 | 1 | 444 |
| 2009 | 5 | 131 | 1 | 540 |
| 2010 | 3 | 142 | 22 | 2,431 |
| 2011 | 5 | 129 | 4 | 1,802 |
| 2012 | 5 | 125 | 1 | 2,277 |
| 2013 | 0 | — | 0 | 2,772 |
| 2014 | 4 | 135 | 1 | 2,740 |
| 2015 | 3 | 124 | 0 | 3,355 |
| 2016 | 1 | — | 0 | 3,374 |
| 2017 | 3 | 214 | 0 | 2,781 |
| 2018 | 0 | — | 2 | 2,416 |
| 2019 | 4 | 126 | 0 | 2,287 |
| 2020 | 4 | 227 | 0 | 1,217 |
| 2021 | 1 | — | 0 | 1,673 |
| 2022 | 4 | 245 | 5 | 1,907 |
| 2023 | 1 | — | 1 | 1,799 |
| 2024 | 5 | 197 | 0 | 2,120 |
| 2025 | 3 | 267 | 1 | 1,799 |
| 2026 | 3 | 115 | 0 | — |
What is it indicated for?
The Infiniti® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The AutoSert™ IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal. The following system…
Read the full statement (141 words)
The Infiniti® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The AutoSert™ IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal.
The following system modalities additionally support the described indications:
- Ultrasound with UltraChopper Tip achieves the functionality of cataract separation.
- AquaLase achieves the functionality for removal of residual cortical material and lens epithelial cells
- The AutoSert™ IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert™ is indicated for use with ACRYSOF lenses SN60WF and SN6AD1, as well as approved AcrySof lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112425: Infiniti Vision System Evergreen II Autosert Iol Injector Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112425
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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