510(k) · Cleared
Recalled · Class II · 2012Stellaris PC Vision Enhancement 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 Aug 17, 2010 as substantially equivalent to K063331 (Bausch & Lomb, Inc., 2006) and 2 other predicates after a 97-day review. Its family tree reaches back 5 generations to 1985. 14 later devices descend from it. It has been recalled once.
- Decided
- Aug 17, 2010
- Review
- 97 days
- Class
- Class II
- Product code
- HQC
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 5 generations to K844373 (1985). 17 ancestors in all. 14 later devices descend from it, 4 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 backK063331 Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · Recalled
- 1 generation backK082473 Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 2009 · Recalled
- This deviceK101325 Stellaris PC Vision Enhancement SystemBausch & Lomb, Inc. · 2010
- Descendant · cites it directly · 7 of its ownK133486 Stellaris PC Vision Enhancement SystemBausch & Lomb · 2014 · Recalled
- Descendant · cites it directly · 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
- Descendant · 2 generations on · 2 of its ownK190875 EVA, anterior machine, EVA, combined machine, EVA combined machine…D.O.R.C. Dutch Ophthalmic Research Center (International) · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK213467 EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K133486Stellaris PC Vision Enhancement SystemBausch & Lomb · 2014 · cites it directly7descendants
- K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Dutch Ophthalmic Research Center International BV · 2015 · cites it directly5descendants
- K133242Stellaris Vision Enhancement SystemBausch & Lomb · 2014 · cites it directly4descendants
- K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…D.O.R.C. Dutch Ophthalmic Research Center (International) · 2019 · 2 generations on2descendants
- K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · 2 generations on1descendant
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 | K063331 | Bausch & Lomb NGX Microsurgical System | Bausch & Lomb, Inc. | 2006 | 12 |
| −1 | K082473 | Bausch & Lomb Stellaris Microsurgical System | Bausch & Lomb, Inc. | 2009 | 4 |
| 0 (this device) | K101325 | Stellaris PC Vision Enhancement System | Bausch & Lomb, Inc. | 2010 | — |
| +1 | K133486 | Stellaris PC Vision Enhancement System | Bausch & Lomb | 2014 | 3 |
| +1 | 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 | — |
| +2 | K190875 | EVA, anterior machine, EVA, combined machine, EVA combined machine with laser… | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2019 | 1 |
| +2 | K213467 | EVA NEXUS Ophthalmic Surgical System | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2022 | 6 |
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 |
|---|---|---|
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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? (3)
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 2…dpieces designated for use with the system. 4. Substantial Equivalence 510(k) Clearance Date Device Description K063331 12/14/2006 Bausch & Lomb TM Stellaris®… | 2006 |
| * | K961310 | Storz Premiere II Microsurgical System (CX Series)Summary page 2…12/14/2006 Bausch & Lomb TM Stellaris® NGX Microsurgical System K96131 0 6/27/1 996 Bausch & Lomb'TM Premiere 11… | 1996 |
| * | K082473 | Bausch & Lomb Stellaris Microsurgical SystemSummary page 2…Millennium® Microsurgical System K082473 1/9/2009 Bausch & Lomb TM Stellaris®D ____… | 2009 |
What descends from it? (14)
See all 144 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 |
|---|---|---|---|---|
| Aug 31, 2012 | Class II | Z-0593-2013 | Process control | Posterior fluidics modules installed in the system may need to be recalibrated. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 9 of the 17 ancestors have a recall of any class.
- Of its descendants, K133486 (Bausch & Lomb, 2014) has gone furthest, with 7 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. 2010, 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 & Lomb Stellaris PC Vision Enhancement 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 phacofragmentation (coaxial or bimanual), irrigation/aspiration, bipolar diathermy, 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/K101325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101325: Stellaris PC Vision Enhancement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101325
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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