510(k) · Cleared
ClearedMojave Cataract Extraction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allergan, Inc. · HQC Unit, Phacofragmentation
Cleared on Feb 13, 2001 after an 81-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 33 later devices descend from it.
- Decided
- Feb 13, 2001
- Review
- 81 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 0
33 later devices descend from it, 2 citing it directly.
- This deviceK003638 Mojave Cataract Extraction SystemAllergan, Inc. · 2001
- Descendant · cites it directly · 32 of its ownK060366 The Amo Ophthalmic Surgical SystemAdvanced Medical Optics, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 24 of its ownK063331 Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 22 of its ownK082473 Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 14 of its ownK101325 Stellaris PC Vision Enhancement SystemBausch & Lomb, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 8 of its ownK081877 Associate 2500 Dual and Compact SystemsDutch Ophthalmic Research Center International BV · 2009
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K060366The Amo Ophthalmic Surgical SystemAdvanced Medical Optics, Inc. · 2006 · cites it directly32descendants
- K063331Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · 2 generations on24descendants
- K082473Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 2009 · 3 generations on22descendants
- K101325Stellaris PC Vision Enhancement SystemBausch & Lomb, Inc. · 2010 · 3 generations on14descendants
- K081877Associate 2500 Dual and Compact SystemsDutch Ophthalmic Research Center International BV · 2009 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003638 | Mojave Cataract Extraction System | Allergan, Inc. | 2001 | — |
| +1 | K060366 | The Amo Ophthalmic Surgical System | Advanced Medical Optics, Inc. | 2006 | 1 |
| +2 | K063331 | Bausch & Lomb NGX Microsurgical System | Bausch & Lomb, Inc. | 2006 | 12 |
| +3 | K082473 | Bausch & Lomb Stellaris Microsurgical System | Bausch & Lomb, Inc. | 2009 | 4 |
| +3 | K101325 | Stellaris PC Vision Enhancement System | Bausch & Lomb, Inc. | 2010 | 1 |
| +2 | K081877 | Associate 2500 Dual and Compact Systems | Dutch Ophthalmic Research Center International BV | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (33)
See all 332 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K060366 (Advanced Medical Optics, Inc., 2006) has gone furthest, with 32 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 | — |
https://510kreport.com/device/K003638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003638: Mojave Cataract Extraction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003638
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026