510(k) · Cleared
Recalled · Class II · 2015Gemini Ophthalmic Surgery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories · HQC Unit, Phacofragmentation
Cleared on Jun 25, 1991 after a 63-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 78 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 25, 1991
- Review
- 63 days
- Class
- Class II
- Product code
- HQC
- Recalls
- 2
- Predicates
- 0
78 later devices descend from it, 14 citing it directly.
- This deviceK911808 Gemini Ophthalmic Surgery SystemAlcon Laboratories · 1991
- Descendant · cites it directly · 59 of its ownK980292 Cataract Liquefracture DeviceAlcon Laboratories · 1998
- Descendant · cites it directly · 50 of its ownK021566 InfinitiAlcon Laboratories, Inc. · 2002 · Recalled
- Descendant · cites it directly · 36 of its ownK063583 Alcon Vision SystemAlcon · 2008 · Recalled
- 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
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 78 · See all- K980292Cataract Liquefracture DeviceAlcon Laboratories · 1998 · cites it directly59descendants
- K021566InfinitiAlcon Laboratories, Inc. · 2002 · cites it directly50descendants
- K063583Alcon Vision SystemAlcon · 2008 · cites it directly36descendants
- K060366The Amo Ophthalmic Surgical SystemAdvanced Medical Optics, Inc. · 2006 · cites it directly32descendants
- K063331Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · 2 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911808 | Gemini Ophthalmic Surgery System | Alcon Laboratories | 1991 | — |
| +1 | K980292 | Cataract Liquefracture Device | Alcon Laboratories | 1998 | — |
| +1 | K021566 | Infiniti | Alcon Laboratories, Inc. | 2002 | 3 |
| +1 | K063583 | Alcon Vision System | Alcon | 2008 | 11 |
| +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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 6 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 5 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (78)
See all 7814 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980292 | Cataract Liquefracture Device | 1998 | 59 |
| K021566 | Infiniti | 2002 | 50 |
| K063583 | Alcon Vision System | 2008 | 36 |
| K060366 | The Amo Ophthalmic Surgical System | 2006 | 32 |
| K082845 | Infiniti Vision System with Ozil IP | 2009 | 22 |
| K121555 | Centurion Vision System | 2012 | 6 |
| K121675 | Versavit | 2012 | 6 |
| K981103 | Turbosonics Limited Reuse Ultrasonic Tip | 1998 | 6 |
| K030179 | Medisiss Phacoemulsification Tips/Needles | 2003 | 4 |
| K955789 | Alcon Series 20000 Legacy Mackool System | 1996 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 2, 2015 | Class II | Z-1940-2015 | Packaging | Insufficient seal on the outside packaging, potentially affecting the sterility of the product. |
| Apr 29, 2009 | Not classified | Z-1643-2009 | Process control | Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that oxidation can occur on some of the blades. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K980292 (Alcon Laboratories, 1998) has gone furthest, with 59 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/K911808 · printed Nov 6, 2026
Cite this page
510(k) Report. “K911808: Gemini Ophthalmic Surgery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911808
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026