510(k) · Cleared
Recalled · Class II · 2026EVA NEXUS Ophthalmic Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
D.O.R.C. Dutch Ophthalmic Research Center (International) · HQC Unit, Phacofragmentation
Cleared on Jun 14, 2022 as substantially equivalent to K190875 (D.O.R.C. Dutch Ophthalmic Research Center (International), 2019) and 4 other predicates after a 229-day review. Its family tree reaches back 9 generations to 1994. 1 later device descends from it. It has been recalled 6 times.
- Decided
- Jun 14, 2022
- Review
- 229 days
- Class
- Class II
- Product code
- HQC
- Recalls
- 6
- Predicates
- 5
Its longest line of descent runs back 9 generations to K933880 (1994). 68 ancestors in all, the oldest K844373 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 5 generations between
- 3 generations backK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- 2 generations backK142877 EVA,anterior machine, EVA, combined machine, EVA combined machine…Dutch Ophthalmic Research Center International BV · 2015
- 1 generation backK190875 EVA, anterior machine, EVA, combined machine, EVA combined machine…D.O.R.C. Dutch Ophthalmic Research Center (International) · 2019 · Recalled
- This deviceK213467 EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022
- Descendant · cites it directly · 0 of its ownK250501 System SophiThis AG · 2025
Show all 9 generations
- Root · 9 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 8 generations backK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
- 7 generations backK964074 Diolite 532Iriderm Div. · 1997
- 6 generations backK982031 Oculight GL with the Dermatology HandpieceIridex Corp · 1998
- 5 generations backK031665 Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003
- 4 generations backK062624 Next Generation LaserAlcon Laboratories · 2007
- 3 generations backK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- 2 generations backK142877 EVA,anterior machine, EVA, combined machine, EVA combined machine…Dutch Ophthalmic Research Center International BV · 2015
- 1 generation backK190875 EVA, anterior machine, EVA, combined machine, EVA combined machine…D.O.R.C. Dutch Ophthalmic Research Center (International) · 2019 · Recalled
- This deviceK213467 EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022
Most influential descendants
Showing 1 of 1 · See all- K250501System SophiThis AG · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K933880 | SL Series Surgical Laser Systems | Laserscope | 1994 | — |
| −8 | K954905 | CB Diode/532 Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −7 | K964074 | Diolite 532 | Iriderm Div. | 1997 | — |
| −6 | K982031 | Oculight GL with the Dermatology Handpiece | Iridex Corp | 1998 | — |
| −5 | K031665 | Iris Medical Oculight GL/GLX Laser Systems | Iridex Corp | 2003 | — |
| −4 | K062624 | Next Generation Laser | Alcon Laboratories | 2007 | — |
| −3 | K101285 | Constellation Vision System | Alcon Manufacturing, Ltd. | 2010 | 4 |
| −2 | K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser… | Dutch Ophthalmic Research Center International BV | 2015 | — |
| −1 | K190875 | EVA, anterior machine, EVA, combined machine, EVA combined machine with laser… | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2019 | 1 |
| 0 (this device) | K213467 | EVA NEXUS Ophthalmic Surgical System | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2022 | — |
| +1 | K250501 | System Sophi | This AG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K190875 | EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Summary page 4…10(k) number Device Predicate for EVA Ophthalmic Surgical System EVA NEXUS™ Ophthalmic Surgical K190875 (DORC) System K142877 8267 and 8268.series vitrectomes… | 2019 |
| * | K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Summary page 4…EVA Ophthalmic Surgical System EVA NEXUS™ Ophthalmic Surgical K190875 (DORC) System K142877 8267 and 8268.series vitrectomes 9268.series vitrectomes K142877 8110.series tubing… | 2015 |
| * | K024061 | Peregrine Straight Laser Probe, Model PD6000.00Summary page 4…K142877 8267 and 8268.series vitrectomes 9268.series vitrectomes K142877 8110.series tubing 9110.series tubing K024061 7525.series stepped laser probes 7227.series directional laser probes… | 2003 |
| * | K203264 | MicroDose InjectorSummary page 4…ped laser probes 7227.series directional laser probes 1364.DD - 1 cc syringe holder for micro K203264 MicroDose™ Injector (MedOne) injection… | 2021 |
| * | K200325 | Orbit Subretinal Delivery SystemSummary page 4…injection Orbit Subretinal Delivery System (Orbit 1364.DD - 1 cc syringe holder for micro K200325 SDS) injection… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250501 | System Sophi | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 30, 2026 | Class II | Z-2323-2026 | Process design | An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use. |
| Apr 30, 2026 | Class II | Z-2324-2026 | Process design | An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use. |
| Apr 30, 2026 | Class II | Z-2322-2026 | Process design | An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use. |
| Jan 15, 2024 | Class II | Z-1333-2024 | Process control | When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely. |
| Jan 15, 2024 | Class II | Z-1332-2024 | Process control | When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely. |
| Jan 15, 2024 | Class II | Z-1331-2024 | Process control | When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 8 companies; a new generation was cleared every 3.0 years on median.
- 19 of the 68 ancestors have a recall of any class.
- Of its descendants, K250501 (This AG, 2025) has gone furthest, with 0 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. 2022, 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 EVA NEXUS™ Ophthalmic Surgical System is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery, including subretinal microinjection of gases or aqueous fluids. In addition, the optional laser is indicated for the following: Condition Diabetic Retinopathy * Proliferative Diabetic Retinopathy * Clinically Significant Macular Edema Retinal Tear and…
Read the full statement (120 words)
The EVA NEXUS™ Ophthalmic Surgical System is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery, including subretinal microinjection of gases or aqueous fluids.
In addition, the optional laser is indicated for the following:
Condition
Diabetic Retinopathy
* Proliferative Diabetic Retinopathy
* Clinically Significant Macular Edema
Retinal Tear and Detachments
Lattice Degeneration
Sub-retinal (choroidal) Neovascularization
Retinal Vascular Occlusion
* Neovascularization secondary to Branch or Central retinal vein occlusion
* Chronic macular edema secondary to Branch or Central retinal vein occlusion
Glaucoma
* Primary Open-angle
* Closed Angle
Treatment
Panretinal Photocoagulation
Focal or Grid Laser
Laser Retinopathy
Retinal Photocoagulation
Focal Laser
Scatter Laser Photocoagulation
Focal or Grid Laser
Trabeculoplasty
Iridotomy or Iridoplasty
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213467 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213467: EVA NEXUS Ophthalmic Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213467
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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