510(k) · Cleared
Recalled · 2010Bausch & Lomb NGX 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 Dec 19, 2006 as substantially equivalent to K961310 (Storz Instrument Co., 1996) and 3 other predicates after a 46-day review. Its family tree reaches back 3 generations to 1985. 24 later devices descend from it. It has been recalled 12 times.
- Decided
- Dec 19, 2006
- Review
- 46 days
- Class
- Class II
- Product code
- HQC
- Recalls
- 12
- Predicates
- 4
Its longest line of descent runs back 3 generations to K844373 (1985). 15 ancestors in all. 24 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK844373 O.M.S. Ultra-PhacoOptical Micro Systems, Inc. · 1985
- 2 generations backK981116 Sovereign Cataract Extraction SystemAllergan, Inc. · 1998 · Recalled
- 1 generation backK021566 InfinitiAlcon Laboratories, Inc. · 2002 · Recalled
- This deviceK063331 Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006
- Descendant · cites it directly · 22 of its ownK082473 Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 2009 · Recalled
- Descendant · cites it directly · 14 of its ownK101325 Stellaris PC Vision Enhancement SystemBausch & Lomb, Inc. · 2010 · Recalled
- Descendant · cites it directly · 8 of its ownK081877 Associate 2500 Dual and Compact SystemsDutch Ophthalmic Research Center International BV · 2009
- Descendant · 2 generations on · 7 of its ownK133486 Stellaris PC Vision Enhancement SystemBausch & Lomb · 2014 · Recalled
- Descendant · 2 generations on · 6 of its ownK121555 Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · Recalled
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K082473Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 2009 · cites it directly22descendants
- K101325Stellaris PC Vision Enhancement SystemBausch & Lomb, Inc. · 2010 · cites it directly14descendants
- K081877Associate 2500 Dual and Compact SystemsDutch Ophthalmic Research Center International BV · 2009 · cites it directly8descendants
- K133486Stellaris PC Vision Enhancement SystemBausch & Lomb · 2014 · 2 generations on7descendants
- K121555Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K844373 | O.M.S. Ultra-Phaco | Optical Micro Systems, Inc. | 1985 | — |
| −2 | K981116 | Sovereign Cataract Extraction System | Allergan, Inc. | 1998 | 1 |
| −1 | K021566 | Infiniti | Alcon Laboratories, Inc. | 2002 | 3 |
| 0 (this device) | K063331 | Bausch & Lomb NGX Microsurgical System | Bausch & Lomb, Inc. | 2006 | — |
| +1 | K082473 | Bausch & Lomb Stellaris Microsurgical System | Bausch & Lomb, Inc. | 2009 | 4 |
| +1 | K101325 | Stellaris PC Vision Enhancement System | Bausch & Lomb, Inc. | 2010 | 1 |
| +1 | K081877 | Associate 2500 Dual and Compact Systems | Dutch Ophthalmic Research Center International BV | 2009 | — |
| +2 | K133486 | Stellaris PC Vision Enhancement System | Bausch & Lomb | 2014 | 3 |
| +2 | K121555 | Centurion Vision System | Alcon Laboratories, Inc. | 2012 | 4 |
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 |
|---|---|---|
| 2009 | 2 | 0 |
| 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 13.4 · 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 |
|---|---|---|---|
| * | K961310 | Storz Premiere II Microsurgical System (CX Series)Summary page 2…s and handpieces designated for use with the system. 4. Substantial Equivalence 510(k) Clearance Date Device Description K961310 6/27/1996 Bausch & Lomb Premiere II… | 1996 |
| * | K060366 | The Amo Ophthalmic Surgical SystemSummary page 2…Millennium Microsurgical System K060366 4/7/2006 AMO Ophthalmic Surgical… | 2006 |
| * | K952213 | Alcon Series 20000 Legacy PhacoemulsifierSummary page 2…K060366 4/7/2006 AMO Ophthalmic Surgical System K952213 8/9/1995 Alcon 2000 Legacy… | 1995 |
| * | K021566 | InfinitiSummary page 2…8/9/1995 Alcon 2000 Legacy Microsurgical System K021566 7/2/2002 Alcon Infiniti Microsurgical… | 2002 |
What descends from it? (24)
See all 244 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 |
|---|---|---|---|---|
| Jan 15, 2010 | Not classified | Z-1664-2010 | Nonconforming Material/Component | The AC power cords used on these products are subject to an FDA Alert -- Safety Investigation of Certain Medical Device Power Cords: Initial Communication, Date Issued: October 19, 2009. |
| Jan 8, 2010 | Not classified | Z-1715-2010 | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate |
| Jan 8, 2010 | Not classified | Z-1722-2010 | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate |
| Jan 8, 2010 | Not classified | Z-1712-2010 | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate |
| Jan 8, 2010 | Not classified | Z-1716-2010 | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate |
| Jan 8, 2010 | Not classified | Z-1721-2010 | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate |
| Jan 8, 2010 | Not classified | Z-1717-2010 | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate |
| Jan 8, 2010 | Not classified | Z-1714-2010 | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate |
| Jan 8, 2010 | Not classified | Z-1713-2010 | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate |
| Jan 8, 2010 | Not classified | Z-1718-2010 | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate |
| Jan 8, 2010 | Not classified | Z-1719-2010 | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate |
| Jan 8, 2010 | Not classified | Z-1720-2010 | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 7 of the 15 ancestors have a recall of any class.
- Of its descendants, K082473 (Bausch & Lomb, Inc., 2009) has gone furthest, with 22 descendants of its own.
- 10 other devices also cite its predicate K961310.
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 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/K063331 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063331: Bausch & Lomb NGX 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/K063331
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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