FDA.reportPublic FDA data

EVA NEXUS™, Phaco vitrectomy system including laser with SMA connector

Primary DI
08717872034447
Brand
EVA NEXUS™, Phaco vitrectomy system including laser with SMA connector
Company
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Model
9000.COMU3
Published
2022-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HQCUnit, Phacofragmentation
HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered
HQFLaser, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQCUnit, PhacofragmentationOphthalmic2
HQEInstrument, Vitreous Aspiration And Cutting, Ac-PoweredOphthalmic2
HQFLaser, OphthalmicOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213467000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213467000EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International)2022-06-14HQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717872034447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717872034447087178720344478717872034447

GMDN Terms#

Term, Definition table
TermDefinition
Phacoemulsification/vitrectomy systemAn assembly of ophthalmic devices intended to deliver energies (e.g., ultrasonic, piezoelectric, high frequency current) through dedicated handpieces and tips that are introduced through an incision or incisions made in the eye, for the purpose of performing phacoemulsification and/or vitrectomy (the removal and replacement of cataracts and/or the vitreous in anterior and posterior segment surgical procedures). It typically consists of a generator providing the energy, irrigation and suction system for the removal of the debris, a tamponade system (e.g., silicone and air), diathermy device, intraocular illuminator, handpieces and cables, the tips/needles/electrodes, and a foot control.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
407522184
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717872031804EVA Custom TDC Vitrectomy Pack VGPC Input 23G8523.4222021-06-11
08717872003221Universal silicone infusion line for 20 gauge/0.9 mm cannula system.1279.IA201279.IA202021-02-01
08717872003245Infusion line for 23G / 0.6 mm infusion cannula 1272.ERPP21279.P1279.P2021-02-01
08717872003993Disposable Backflush instrument, with extended silicone tip and active aspiratio1281.TDM1281.TDM2021-02-02
08717872004013Replacement backflush reservoir with active aspiration.1281.XD1281.XD2021-02-02
08717872004075MVR Blade 23-G, angled1282.D061282.D062021-02-09
08717872004099One step stiletto insertor.(23 gauge / 0.6 mm)1282.F061282.F062021-02-09
08717872007403Disposable keratoscope1420.D1420.D2023-09-14
08717872012339Crescent Knife, 2.25, 55°, bevel up51.111851.11182021-01-29
08717872012346Slit Knife, 2.2mm, angled 45°, bibevel51.372251.37222021-01-29
08717872012384MVR Blade 20G, straight51.523051.52302021-01-29
08717872015255Universal silicone infusion line for 20 gauge/0.9 mm cannula system, suitable fo1279.IA20S1279.IA20S2021-02-01
08717872015712MVR Blade 20G, angled52.522052.52202021-01-29
08717872015736Trapezoid Knife 1.2 x 1.4mm, angled53.121453.12142021-01-29
08717872015743Slit Knife, 2.2mm, angled, bevel up53.372253.37222021-01-29
08717872015750Slit Knife, 2.75mm, angled, bevel up53.372753.37272021-01-29
08717872015798Clear Corneal Knife, 2.5mm, angled54.572554.57252021-01-29
08717872015934Stab Knife, 15°51.489151.48912021-01-29
08717872031811EVA Custom TDC Vitrectomy Pack VGPC Input 25G8525.4098525.4012021-06-11
08717872031828EVA Custom TDC Vitrectomy Pack VGPC Input 27G8527.4068525.4012021-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630055210319Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07630055210326Phaco Set Sophi - 21G/30°This AGHQC2026-02-11
07630055210333Phaco Set Sophi - 23G/30°This AGHQC2026-02-11
07630055210807Phaco Set Sophi - 20G/CurvedThis AGHQC2026-02-11
07630055210814Phaco Set Sophi - 21G/CurvedThis AGHQC2026-02-11
07630055210821Phaco Set Sophi - 23G/CurvedThis AGHQC2026-02-11
07630055252883HighVac Phaco Set Sophi - 21G/30° 0.45This AGHQC2026-02-11
07630055253293Dynamic Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07640179410762Cassette Peristaltic Sophi This AGHQC2026-02-11
07640179410786Cassette Peristaltic & Venturi SophiThis AGHQC2026-02-11
07640179410809Cassette Peristaltic Sophi ECOThis AGHQC2026-02-11
07630003915709Oertli®Oertli-Instrumente AGHQC2024-10-15
08717872014142Directional Laser Probe with Alcon / Lumenis connector.(20 gauge / 0.9 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014173Directional Laser Probe with Alcon / Lumenis connector.(23 gauge / 0.6 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014203Directional Laser Probe with Alcon / Lumenis connector.(25 gauge / 0.5 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014968Directional Laser Probe with DORC connector.(25 gauge / 0.5 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014975Directional Laser Probe with DORC connector.(20 gauge / 0.9 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014982Directional Laser Probe with DORC connector.(23 gauge / 0.6 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872030319Disposable test chamber for phaco handpieceD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2020-11-19
07630003912319Oertli®Oertli-Instrumente AGHQC2020-06-24
07630003912333Oertli®Oertli-Instrumente AGHQC2020-06-24
07630003912340Oertli®Oertli-Instrumente AGHQC2020-06-24
08717872030135EVA Custom TDC Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2020-04-14
08717872030135EVA Custom TDC Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2020-04-14
08717872030166EVA TDC Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2020-04-14
08717872030272Disposable infusion sleeve for 1.8 mm phaco needle including test chamber.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2020-02-13
08717872030289Disposable infusion sleeve for 2.2 mm phaco needle including test chamber.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2020-02-13
08717872030296Disposable infusion sleeve for 2.4 mm phaco needle including test chamber.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2020-02-13
08717872030302Disposable infusion sleeve for 2.8 mm phaco needle including test chamber.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2020-02-13
08717872030364Reusable phaco sleeve 1.8 mmD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2020-02-10