510(k) · Cleared
ClearedInfiniti Vision System with Ozil IP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Research, Ltd. · HQC Unit, Phacofragmentation
Cleared on Feb 12, 2009 as substantially equivalent to K021566 (Alcon Laboratories, Inc., 2002) and 3 other predicates after a 139-day review. Its family tree reaches back 4 generations to 1985. 22 later devices descend from it.
- Decided
- Feb 12, 2009
- Review
- 139 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K844373 (1985). 15 ancestors in all. 22 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK844373 O.M.S. Ultra-PhacoOptical Micro Systems, Inc. · 1985
- 3 generations backK981116 Sovereign Cataract Extraction SystemAllergan, Inc. · 1998 · Recalled
- 2 generations backK021566 InfinitiAlcon Laboratories, Inc. · 2002 · Recalled
- 1 generation backK063583 Alcon Vision SystemAlcon · 2008 · Recalled
- This deviceK082845 Infiniti Vision System with Ozil IPAlcon Research, Ltd. · 2009
- Descendant · cites it directly · 12 of its ownK102727 Lensar Laser System for Anterior CapsulotomyLensar, Inc. · 2011
- Descendant · cites it directly · 8 of its ownK112425 Infiniti Vision System Evergreen II Autosert Iol Injector HandpieceAlcon Manufacturing, Ltd. · 2011
- Descendant · 2 generations on · 7 of its ownK112098 TBDLensar, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK121555 Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 6 of its ownK120214 TBDLensar, Inc. · 2012
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K102727Lensar Laser System for Anterior CapsulotomyLensar, Inc. · 2011 · cites it directly12descendants
- K112425Infiniti Vision System Evergreen II Autosert Iol Injector HandpieceAlcon Manufacturing, Ltd. · 2011 · cites it directly8descendants
- K112098TBDLensar, Inc. · 2011 · 2 generations on7descendants
- K121555Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · cites it directly6descendants
- K120214TBDLensar, Inc. · 2012 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K844373 | O.M.S. Ultra-Phaco | Optical Micro Systems, Inc. | 1985 | — |
| −3 | K981116 | Sovereign Cataract Extraction System | Allergan, Inc. | 1998 | 1 |
| −2 | K021566 | Infiniti | Alcon Laboratories, Inc. | 2002 | 3 |
| −1 | K063583 | Alcon Vision System | Alcon | 2008 | 11 |
| 0 (this device) | K082845 | Infiniti Vision System with Ozil IP | Alcon Research, Ltd. | 2009 | — |
| +1 | K102727 | Lensar Laser System for Anterior Capsulotomy | Lensar, Inc. | 2011 | — |
| +1 | K112425 | Infiniti Vision System Evergreen II Autosert Iol Injector Handpiece | Alcon Manufacturing, Ltd. | 2011 | — |
| +2 | K112098 | TBD | Lensar, Inc. | 2011 | — |
| +1 | K121555 | Centurion Vision System | Alcon Laboratories, Inc. | 2012 | 4 |
| +2 | K120214 | TBD | Lensar, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2017 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 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? (4)
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…) 5.1. Predicate Devices: The legally marketed devices(s) to which We. are claiming equivalence to are: 510(k) Number Device K021566 Infiniti* Vision System K981116 Sovereign* Cataract Extraction System K063583… | 2002 |
| * | K981116 | Sovereign Cataract Extraction SystemSummary page 1…y marketed devices(s) to which We. are claiming equivalence to are: 510(k) Number Device K021566 Infiniti* Vision System K981116 Sovereign* Cataract Extraction System K063583 Alcon Vision System (Constellation) K… | 1998 |
| * | K063583 | Alcon Vision SystemSummary page 1…510(k) Number Device K021566 Infiniti* Vision System K981116 Sovereign* Cataract Extraction System K063583 Alcon Vision System (Constellation) K9 11808 Gemmin Ophthalmic Surgery S ,tem… | 2008 |
| * | K911808 | Gemini Ophthalmic Surgery SystemSummary page 1…Infiniti* Vision System K981116 Sovereign* Cataract Extraction System K063583 Alcon Vision System (Constellation) K9 11808 Gemmin Ophthalmic Surgery S ,tem (Marketed as the Series 20000 Legacy® (STTL) and A… | 1991 |
What descends from it? (22)
See all 225 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 24 years and passes through 5 companies; a new generation was cleared every 5.9 years on median.
- 7 of the 15 ancestors have a recall of any class.
- Of its descendants, K102727 (Lensar, Inc., 2011) has gone furthest, with 12 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. 2009, 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 with OZil®IP is indicated for emulsification and removal of cataracts, vitreous aspiration and cutting associated with anterior vitrectomy, and bipolar coagulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082845 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082845: Infiniti Vision System with Ozil IP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082845
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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