510(k) · Cleared
Recalled · 2010Phaco Chop Needles
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 16, 2004 after a 21-day review. The FDA summary names its predicate without a number. 21 later devices descend from it. It has been recalled 11 times.
- Decided
- Aug 16, 2004
- Review
- 21 days
- Class
- Class II
- Product code
- HQC
- Recalls
- 11
- Predicates
- 0
21 later devices descend from it, 1 citing it directly.
- This deviceK041998 Phaco Chop NeedlesBausch & Lomb, Inc. · 2004
- Descendant · cites it directly · 20 of its ownK091777 Alcon UltrachopperAlcon Research, Ltd. · 2009
- Descendant · 2 generations on · 17 of its ownK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- Descendant · 2 generations on · 8 of its ownK112425 Infiniti Vision System Evergreen II Autosert Iol Injector HandpieceAlcon Manufacturing, Ltd. · 2011
- Descendant · 2 generations on · 6 of its ownK121555 Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 5 of its ownK142877 EVA,anterior machine, EVA, combined machine, EVA combined machine…Dutch Ophthalmic Research Center International BV · 2015
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K091777Alcon UltrachopperAlcon Research, Ltd. · 2009 · cites it directly20descendants
- K101285Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · 2 generations on17descendants
- K112425Infiniti Vision System Evergreen II Autosert Iol Injector HandpieceAlcon Manufacturing, Ltd. · 2011 · 2 generations on8descendants
- K121555Centurion Vision SystemAlcon Laboratories, Inc. · 2012 · 2 generations on6descendants
- K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Dutch Ophthalmic Research Center International BV · 2015 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041998 | Phaco Chop Needles | Bausch & Lomb, Inc. | 2004 | — |
| +1 | K091777 | Alcon Ultrachopper | Alcon Research, Ltd. | 2009 | — |
| +2 | K101285 | Constellation Vision System | Alcon Manufacturing, Ltd. | 2010 | 4 |
| +2 | K112425 | Infiniti Vision System Evergreen II Autosert Iol Injector Handpiece | Alcon Manufacturing, Ltd. | 2011 | — |
| +2 | K121555 | Centurion Vision System | Alcon Laboratories, Inc. | 2012 | 4 |
| +3 | K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser… | Dutch Ophthalmic Research Center International BV | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | — | Standard Phaco Needle Named without a submission number | |
| * | — | MicroFlow Phaco Needle Named without a submission number | |
| * | — | MicroFlow+ Phaco Needle Named without a submission number |
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091777 | Alcon Ultrachopper | 2009 | 20 |
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-1729-2010 | 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-1728-2010 | Component design/selection | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate |
| Mar 26, 2008 | Not classified | Z-2051-2008 | Labeling Change Control | The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable |
| Mar 26, 2008 | Not classified | Z-2046-2008 | Labeling Change Control | The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable |
| Mar 26, 2008 | Not classified | Z-2044-2008 | Labeling Change Control | The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable |
| Mar 26, 2008 | Not classified | Z-2049-2008 | Labeling Change Control | The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable |
| Mar 26, 2008 | Not classified | Z-2052-2008 | Labeling Change Control | The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable |
| Mar 26, 2008 | Not classified | Z-2045-2008 | Labeling Change Control | The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable |
| Mar 26, 2008 | Not classified | Z-2047-2008 | Labeling Change Control | The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable |
| Mar 26, 2008 | Not classified | Z-2048-2008 | Labeling Change Control | The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable |
| Mar 26, 2008 | Not classified | Z-2050-2008 | Labeling Change Control | The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K091777 (Alcon Research, Ltd., 2009) has gone furthest, with 20 descendants of its own.
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 Phaco Needles are intended for use with a Bausch & Lomb Millennium, Protege or Premiere Microsurgical System for the emulsification of an opacified crystalline lens.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041998 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041998: Phaco Chop Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041998
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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