D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
ZUIDLAND Zuid-Holland, NL
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. appears in FDA device records in ZUIDLAND Zuid-Holland, NL. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- D.O.R.C. Dutch Opthalmic Research Center Intl B.V.enforcement report, recall
510(k) clearance history
FDA records hold 2 510(k) clearances for D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. between 2019 and 2022. The busiest year on record is 2019, with 1. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213467 | EVA NEXUS Ophthalmic Surgical System | HQC | Substantially Equivalent | |
| K190875 | EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) | HQC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9611516 | 3002806863 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | SCHEIJDELVEWEG 2, ZUIDLAND Zuid-Holland NL-3214 VN NL | 2026 | and 14 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HMXCannula, Ophthalmic
- NGYCannula, Trocar, Ophthalmic
- HOCClip, Iris Retractor
- HNXDepressor, Orbital
- KYGDevice, Irrigation, Ocular Surgery
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- MPAEndoilluminator
- HNRForceps, Ophthalmic
- HQXImplant, Orbital, Extra-Ocular
- HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered
- HNNKnife, Ophthalmic
- HQFLaser, Ophthalmic
- HJKLens, Contact, Polymethylmethacrylate, Diagnostic
- GDMNeedle, Aspiration And Injection, Reusable
- HQBPhotocoagulator And Accessories
- HJAPhotokeratoscope
- GEXPowered Laser Surgical Instrument
- HNFScissors, Ophthalmic
- HNDSpatula, Ophthalmic
- HNCSpecula, Ophthalmic
- FMFSyringe, Piston
- FSMTray, Surgical, Instrument
- HRNUnit, Cryophthalmic, Ac-Powered
- HQCUnit, Phacofragmentation
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2324-2026 | TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 9311.27K02, 9311.27K03, 9627.G0101, 9627.G0201, 9311.27G01-00; | An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use. | Class II | Open, Classified | |
| Z-2323-2026 | TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201; | An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use. | Class II | Open, Classified | |
| Z-2322-2026 | TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01, 9311.23K02, 9311.23K03, 9623.G0201, 9623.G0202, 9623.K0201, 9311.23G01-00; | An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use. | Class II | Open, Classified | |
| Z-1333-2024 | Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm) | 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. | Class II | Open, Classified | |
| Z-1332-2024 | Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm) | 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. | Class II | Open, Classified | |
| Z-1331-2024 | Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm) | 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. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain