# K190875: EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)

- Pathway: 510(k) (Traditional)
- Applicant: D.O.R.C. Dutch Ophthalmic Research Center (International)
- Decided: Sep 25, 2019 after 174 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K933880 (1994). 57 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 5.
- K101285: Constellation Vision System, Alcon Manufacturing, Ltd. (2010) Summary page 5.
- K133486: Stellaris PC Vision Enhancement System, Bausch & Lomb (2014) Summary page 5.

## Most influential descendants
- K213467: EVA NEXUS Ophthalmic Surgical System (2022), 1 descendant of its own
- K250501: System Sophi (2025), 0 descendants of its own

## Recalls of this device
- May 21, 2019 · Class II · Z-2252-2021: Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line

## Indications for use
The EVA Ophthalmic surgical system is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery. In addition, the optional laser is indicated for the following: Condition: Treatment: Diabetic Retinopathy * Proliferative Diabetic Retinopathy..........................Panretinal Photocoagulation * Clinically Significant Macular Edema....................Focal or Grid Laser Retinal Tear and Detachments....................................Laser Retinopathy Lattics Degeneration...................................................Retinal Photocoagulation Sub-retinal (choroidal) Neovascularization................Focal laser Retinal Vascular Occlusion * Neovascularization secondary to Branch or Central retinal vein occlusion...............................Scatter Laser Photocoagulation * Chronic macular edema secondary to Branch or Central retinal vein occlusion...............................Focal or Grid Laser Glaucoma * Primary Open-angle..................................................Trabeculoplasty * Closed Angle.............................................................Iridotomy or Iridoplasty

Source page: https://510kreport.com/device/K190875
Methodology: https://510kreport.com/methodology