510(k) · Cleared
Recalled · 2011Bausch & Lomb Stellaris Microsurgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Inc. · HQC Unit, Phacofragmentation
Cleared on Jan 5, 2009 as substantially equivalent to K063331 (Bausch & Lomb, Inc., 2006) and 1 other predicate after a 131-day review. Its family tree reaches back 4 generations to 1985. 22 later devices descend from it. It has been recalled 4 times.
- Decided
- Jan 5, 2009
- Review
- 131 days
- Class
- Class II
- Product code
- HQC
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 4 generations to K844373 (1985). 16 ancestors in all. 22 later devices descend from it, 3 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 backK063331 Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · Recalled
- This deviceK082473 Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 2009
- Descendant · cites it directly · 14 of its ownK101325 Stellaris PC Vision Enhancement SystemBausch & Lomb, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 7 of its ownK133486 Stellaris PC Vision Enhancement SystemBausch & Lomb · 2014 · Recalled
- Descendant · cites it directly · 6 of its ownK121555 Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 5 of its ownK142877 EVA,anterior machine, EVA, combined machine, EVA combined machine…Dutch Ophthalmic Research Center International BV · 2015
- Descendant · cites it directly · 4 of its ownK133242 Stellaris Vision Enhancement SystemBausch & Lomb · 2014
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K101325Stellaris PC Vision Enhancement SystemBausch & Lomb, Inc. · 2010 · cites it directly14descendants
- K133486Stellaris PC Vision Enhancement SystemBausch & Lomb · 2014 · 2 generations on7descendants
- K121555Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · cites it directly6descendants
- K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Dutch Ophthalmic Research Center International BV · 2015 · 2 generations on5descendants
- K133242Stellaris Vision Enhancement SystemBausch & Lomb · 2014 · cites it directly4descendants
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 | K063331 | Bausch & Lomb NGX Microsurgical System | Bausch & Lomb, Inc. | 2006 | 12 |
| 0 (this device) | K082473 | Bausch & Lomb Stellaris Microsurgical System | Bausch & Lomb, Inc. | 2009 | — |
| +1 | K101325 | Stellaris PC Vision Enhancement System | Bausch & Lomb, Inc. | 2010 | 1 |
| +2 | K133486 | Stellaris PC Vision Enhancement System | Bausch & Lomb | 2014 | 3 |
| +1 | K121555 | Centurion Vision System | Alcon Laboratories, Inc. | 2012 | 4 |
| +2 | K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser… | Dutch Ophthalmic Research Center International BV | 2015 | — |
| +1 | K133242 | Stellaris Vision Enhancement System | Bausch & Lomb | 2014 | — |
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 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 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 13.5 · 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? (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 |
|---|---|---|---|
| * | K063331 | Bausch & Lomb NGX Microsurgical SystemSummary page 1…agmentation and Vitreous aspirating and cutting- anterior vitrectomy. The Stellaris system is a next generation system based on.the system, and has been cleared under K063331 for anterior segment Millennium phacoemulsification vitreous (posterior). The modification to the current Stellaris system pro… | 2006 |
| * | K961310 | Storz Premiere II Microsurgical System (CX Series)Summary page 2…Microsurgical System (Stellaris) K96131 0 6/27/1996 Bausch & Lomb Premiere II… | 1996 |
What descends from it? (22)
See all 223 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 27, 2011 | Not classified | Z-3088-2011 | Nonconforming Material/Component | The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction |
| Jul 27, 2011 | Not classified | Z-3090-2011 | Nonconforming Material/Component | The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction |
| Jul 27, 2011 | Not classified | Z-3087-2011 | Nonconforming Material/Component | The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction |
| Jul 27, 2011 | Not classified | Z-3089-2011 | Nonconforming Material/Component | The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 8 of the 16 ancestors have a recall of any class.
- Of its descendants, K101325 (Bausch & Lomb, Inc., 2010) has gone furthest, with 14 descendants of its own.
- 3 other devices also cite its predicate K063331.
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 Bausch & LombTM NGX Microsurgical System device is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, irrigation/aspiration, bipolar, coaxial, and bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. Use only Bausch & Lomb disposable packs and handpieces designated for use with the system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082473 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082473: Bausch & Lomb Stellaris Microsurgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082473
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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