# K213467: EVA NEXUS Ophthalmic Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: D.O.R.C. Dutch Ophthalmic Research Center (International)
- Decided: Jun 14, 2022 after 229 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K933880 (1994). 68 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190875: EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector), D.O.R.C. Dutch Ophthalmic Research Center (International) (2019) Summary page 4.
- K142877: EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser SMA connector), Dutch Ophthalmic Research Center International BV (2015) Summary page 4.
- K024061: Peregrine Straight Laser Probe, Model PD6000.00, Peregrine Surgical, Ltd. (2003) Summary page 4.
- K203264: MicroDose Injector, Medone Surgical, Inc. (2021) Summary page 4.
- K200325: Orbit Subretinal Delivery System, Orbit Biomedical (2020) Summary page 4.

## Most influential descendants
- K250501: System Sophi (2025), 0 descendants of its own

## Recalls of this device
- Apr 30, 2026 · Class II · Z-2323-2026: 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: 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: 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: 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: 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: 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.

## Indications for use
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

Source page: https://510kreport.com/device/K213467
Methodology: https://510kreport.com/methodology