510(k) · Cleared
Recalled · 2010Millennium Microsurgical System and Peristaltic Phaco Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Inc. · HQF Laser, Ophthalmic
Cleared on Feb 10, 2004 as substantially equivalent to K911808 (Alcon Laboratories, 1991) and 1 other predicate after a 53-day review. Its family tree reaches back 2 generations to 1985. It has been recalled once.
- Decided
- Feb 10, 2004
- Review
- 53 days
- Class
- Class II
- Product code
- HQF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K844373 (1985). 7 ancestors in all. No later device cites it as a predicate yet.
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) | K033941 | Millennium Microsurgical System and Peristaltic Phaco Pack | Bausch & Lomb, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 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 HQF? 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 HQF device
- #1 K251772 Navilas Laser System 577sl (156691)score 13.6 · 12 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 2…rgan Sovereign Similarities The MillenniumTM Peristaltic Pump Module is substantially equivalent to the Alcon Legacy cleared via the 510(k) process, #K911808 and the Allergan Sovereign cleared via the 510(k) process, #K981116 in that they all utilize a peristaltic pump for anter… | 1991 |
| * | K981116 | Sovereign Cataract Extraction SystemSummary page 2…dule is substantially equivalent to the Alcon Legacy cleared via the 510(k) process, #K911808 and the Allergan Sovereign cleared via the 510(k) process, #K981116 in that they all utilize a peristaltic pump for anterior ophthalmic procedures. Differences The main differen… | 1998 |
| * | — | Millennium Microsurgical System Named without a submission number | |
| * | — | Millennium Concentrix Module Named without a submission number | |
| * | — | Millennium Venturi Module Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 8, 2010 | Not classified | Z-1710-2010 | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
- 4 of the 7 ancestors have a recall of any class.
- 13 other devices also cite its predicate K911808.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQF
264in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQF
106in 2025
MAUDE reports naming product code HQF, 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 | 4 | 198 | 2 | 60 |
| 2008 | 3 | 28 | 1 | 34 |
| 2009 | 7 | 115 | 2 | 33 |
| 2010 | 2 | — | 3 | 43 |
| 2011 | 4 | 128 | 5 | 26 |
| 2012 | 5 | 179 | 1 | 41 |
| 2013 | 6 | 225 | 2 | 39 |
| 2014 | 3 | 215 | 4 | 58 |
| 2015 | 4 | 295 | 0 | 80 |
| 2016 | 3 | 271 | 0 | 108 |
| 2017 | 3 | 189 | 0 | 77 |
| 2018 | 1 | — | 0 | 82 |
| 2019 | 4 | 107 | 0 | 66 |
| 2020 | 4 | 53 | 0 | 72 |
| 2021 | 1 | — | 0 | 100 |
| 2022 | 7 | 86 | 0 | 111 |
| 2023 | 5 | 155 | 0 | 92 |
| 2024 | 3 | 167 | 0 | 75 |
| 2025 | 3 | 264 | 1 | 106 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Millennium Peristaltic Pump System
The Bausch & Lomb (B&L) Millennium Peristaltic Pump System is intended for the introduction of Balanced Salt Solution (BSS) into the eye, as well as, the aspiration of fluid/tissue from the eye during ophthalmic anterior surgery. The Millennium Peristaltic Pump System consists of the B&L CX4100 module to be used with the B&L Millennium Microsurgical System and the B&L Peristaltic Phaco Pack, CX5310 sterile single-use accessory pack which consists of the various components/accessories necessary to enable the use of B&L Anterior Handpieces with the Millennium Microsurgical System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033941 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033941: Millennium Microsurgical System and Peristaltic Phaco Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033941
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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