510(k) · Cleared
Recalled · Class II · 2023Infiniti
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories, Inc. · HQC Unit, Phacofragmentation
Cleared on Jul 2, 2002 as substantially equivalent to K911808 (Alcon Laboratories, 1991) and 4 other predicates after a 50-day review. Its family tree reaches back 2 generations to 1985. 50 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 2, 2002
- Review
- 50 days
- Class
- Class II
- Product code
- HQC
- Recalls
- 3
- Predicates
- 5
Its longest line of descent runs back 2 generations to K844373 (1985). 11 ancestors in all. 50 later devices descend from it, 10 citing it directly.
- Root · 2 generations backK844373 O.M.S. Ultra-PhacoOptical Micro Systems, Inc. · 1985
- 1 generation backK981116 Sovereign Cataract Extraction SystemAllergan, Inc. · 1998 · Recalled
- This deviceK021566 InfinitiAlcon Laboratories, Inc. · 2002
- Descendant · cites it directly · 36 of its ownK063583 Alcon Vision SystemAlcon · 2008 · Recalled
- Descendant · cites it directly · 24 of its ownK063331 Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · Recalled
- Descendant · cites it directly · 22 of its ownK082845 Infiniti Vision System with Ozil IPAlcon Research, Ltd. · 2009
- Descendant · 2 generations on · 22 of its ownK082473 Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 2009 · Recalled
- Descendant · cites it directly · 20 of its ownK091777 Alcon UltrachopperAlcon Research, Ltd. · 2009
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K063583Alcon Vision SystemAlcon · 2008 · cites it directly36descendants
- K063331Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · cites it directly24descendants
- K082845Infiniti Vision System with Ozil IPAlcon Research, Ltd. · 2009 · cites it directly22descendants
- K082473Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 2009 · 2 generations on22descendants
- K091777Alcon UltrachopperAlcon Research, Ltd. · 2009 · cites it directly20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K844373 | O.M.S. Ultra-Phaco | Optical Micro Systems, Inc. | 1985 | — |
| −1 | K981116 | Sovereign Cataract Extraction System | Allergan, Inc. | 1998 | 1 |
| 0 (this device) | K021566 | Infiniti | Alcon Laboratories, Inc. | 2002 | — |
| +1 | K063583 | Alcon Vision System | Alcon | 2008 | 11 |
| +1 | K063331 | Bausch & Lomb NGX Microsurgical System | Bausch & Lomb, Inc. | 2006 | 12 |
| +1 | K082845 | Infiniti Vision System with Ozil IP | Alcon Research, Ltd. | 2009 | — |
| +2 | K082473 | Bausch & Lomb Stellaris Microsurgical System | Bausch & Lomb, Inc. | 2009 | 4 |
| +1 | K091777 | Alcon Ultrachopper | Alcon Research, Ltd. | 2009 | — |
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 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2017 | 7 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 5 | 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 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 |
|---|---|---|---|
| * | K911808 | Gemini Ophthalmic Surgery SystemSummary page 1…entation System (per 2 1 CFR 886.4670) 1. Predicate Devices: The legally marketed devices(s) to which we are claiming equivalence to are: 510(k) Number Device K911808 Gemini Ophthalmic Surgery System (Marketed as the Series 20000* Legay@(STTL) and Accurus*) K981… | 1991 |
| * | K981116 | Sovereign Cataract Extraction SystemSummary page 1…o are: 510(k) Number Device K911808 Gemini Ophthalmic Surgery System (Marketed as the Series 20000* Legay@(STTL) and Accurus*) K981116 Sovereign* Cataract Extraction System K961310 Storz Premiere" I1 Microsurgical System K980292… | 1998 |
| * | K961310 | Storz Premiere II Microsurgical System (CX Series)Summary page 1…mini Ophthalmic Surgery System (Marketed as the Series 20000* Legay@(STTL) and Accurus*) K981116 Sovereign* Cataract Extraction System K961310 Storz Premiere" I1 Microsurgical System K980292 Cataract Liquefracture Device (Marketed as AquaLaseTM)… | 1996 |
| * | K980292 | Cataract Liquefracture DeviceSummary page 1…as the Series 20000* Legay@(STTL) and Accurus*) K981116 Sovereign* Cataract Extraction System K961310 Storz Premiere" I1 Microsurgical System K980292 Cataract Liquefracture Device (Marketed as AquaLaseTM) K92563 1 Phacotron Gold* Multifunction Ultrasonic… | 1998 |
| * | K925631 | Phacotron Gold Multifunction Ultrasonic HandpieceSummary page 1…ign* Cataract Extraction System K961310 Storz Premiere" I1 Microsurgical System K980292 Cataract Liquefracture Device (Marketed as AquaLaseTM) K92563 1 Phacotron Gold* Multifunction Ultrasonic (Tmesis*) Handpiece 2. Device Description The InfinitiW is a cataract extr… | 1993 |
What descends from it? (50)
See all 5010 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063583 | Alcon Vision System | 2008 | 36 |
| K063331 | Bausch & Lomb NGX Microsurgical System | 2006 | 24 |
| K082845 | Infiniti Vision System with Ozil IP | 2009 | 22 |
| K091777 | Alcon Ultrachopper | 2009 | 20 |
| K102727 | Lensar Laser System for Anterior Capsulotomy | 2011 | 12 |
| K093210 | Aqualase Capsule Wash Tip | 2010 | 9 |
| K112425 | Infiniti Vision System Evergreen II Autosert Iol Injector Handpiece | 2011 | 8 |
| K081877 | Associate 2500 Dual and Compact Systems | 2009 | 8 |
| K120912 | Infiniti (R) Vision System | 2012 | 3 |
| K141065 | Constellation Vision System | 2014 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 28, 2023 | Class II | Z-2408-2023 | Process control | Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench. |
| Jul 28, 2016 | Class II | Z-2834-2016 | Labeling Change Control | Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU) |
| Oct 6, 2014 | Class II | Z-1597-2016 | Process change control | The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
- 5 of the 11 ancestors have a recall of any class.
- Of its descendants, K063583 (Alcon, 2008) has gone furthest, with 36 descendants of its own.
- 13 other devices also cite its predicate K911808.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 intended use of this device is emulsification and removal of cataracts, as well as associated procedures such as vitreous aspiration and cutting along with bipolar coagulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021566 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021566: Infiniti.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021566
Report an extraction error
Are you the manufacturer?
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