Data / Medical devices / Netherlands / D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.: FDA-registered device maker in ZUIDLAND Zuid-Holland, Netherlands, 13 510(k) clearances
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. is registered with the FDA (registration 9611516) in ZUIDLAND Zuid-Holland, Netherlands. It lists 24 device types. The FDA files 13 510(k) clearances under its listings, the newest dated June 14, 2022. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9611516
- FEI number
- 3002806863
- Address
- Scheijdelveweg 2, ZUIDLAND Zuid-Holland, Netherlands, NL-3214 VN
- Owner or operator
- D.O.R.C. Dutch Ophthalmic Research Center (International) B. (8030460)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- May 13, 1983
- Registered through
- 2026
- Brand names listed
- 1cc syringe holder for micro-injection, 27G Chandelier fiber and 23G standard D-style fiber optic handpiece incl. guidance needle., 27G Ultra Short Disposable 8000 CPM TDC cutter, 27G Ultra Short Disposable One-Step cannula system, 27G Ultra Short Shielded TotalView Endoillumination Probe, Including scleral depressor, Accessory: Protection cap for microforceps & microscissors., Akgul Biopsy Forceps with sharp tip, Anaesthetic Cannula, Retrobulbar Atkinson and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Ophthalmic | HMX | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cannula, Trocar, Ophthalmic | NGY | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Clip, Iris Retractor | HOC | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Depressor, Orbital | HNX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Device, Irrigation, Ocular Surgery | KYG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Exporter to the US | accessdata.fda.gov |
| Endoilluminator | MPA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Forceps, Ophthalmic | HNR | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Implant, Orbital, Extra-Ocular | HQX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | HQE | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Knife, Ophthalmic | HNN | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Laser, Ophthalmic | HQF | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Lens, Contact, Polymethylmethacrylate, Diagnostic | HJK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Reusable | GDM | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Photocoagulator And Accessories | HQB | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Photokeratoscope | HJA | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Ophthalmic | HNF | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Spatula, Ophthalmic | HND | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Specula, Ophthalmic | HNC | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Unit, Cryophthalmic, Ac-Powered | HRN | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Unit, Phacofragmentation | HQC | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 14, 2022 | K213467 | EVA NEXUS Ophthalmic Surgical System | HQC | Substantially Equivalent | D.O.R.C. Dutch Ophthalmic Research Center (International) | accessdata.fda.gov |
| September 25, 2019 | K190875 | EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) | HQC | Substantially Equivalent | D.O.R.C. Dutch Ophthalmic Research Center (International) | accessdata.fda.gov |
| January 23, 2017 | K160591 | D.O.R.C. Disposable Cryo Probe | HRN | Substantially Equivalent | Dutch Ophthalmic Research Center International BV | accessdata.fda.gov |
| March 13, 2015 | K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector) | HQC | Substantially Equivalent | Dutch Ophthalmic Research Center International BV | accessdata.fda.gov |
| November 14, 2013 | K132614 | PEREGRINE CURVED ILLUMINATING LASER PROBE | HQB | Substantially Equivalent | Peregrine Surgical , Ltd. | accessdata.fda.gov |
| January 5, 2009 | K081877 | ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS | HQC | Substantially Equivalent | Dutch Ophthalmic Research Center International BV | accessdata.fda.gov |
| October 13, 2006 | K062895 | XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII | MPA | Substantially Equivalent | Dutch Ophthalmic Research Center International BV | accessdata.fda.gov |
| February 20, 2004 | K033950 | DORC VITRECTOMY LENSES, MODEL 1284 SERIES | HJK | Substantially Equivalent | Dutch Ophthalmic Research Center (D.O.R.C.) | accessdata.fda.gov |
| June 27, 2003 | K031023 | PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10 | HQF | Substantially Equivalent | Peregrine Surgical , Ltd. | accessdata.fda.gov |
| March 7, 2003 | K024061 | PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00 | GEX | Substantially Equivalent | Peregrine Surgical , Ltd. | accessdata.fda.gov |
| January 8, 2003 | K023481 | MICROVISION SCLERAL BUCKLING COMPONENTS | HQX | Substantially Equivalent | Microvision, Inc. | accessdata.fda.gov |
| October 22, 2001 | K012821 | D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM | HRN | Substantially Equivalent | Dutch Ophthalmic USA, Inc. | accessdata.fda.gov |
| November 5, 1991 | K913514 | ELECTROSURGICAL UNIT CABLE | GEI | Substantially Equivalent | Kirwan Surgical Products, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 30, 2026 | 98814 | Class II | Ongoing | 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. | accessdata.fda.gov |
| January 15, 2024 | 94022 | Class II | Ongoing | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Cannula, Ophthalmic
- All makers of Scissors, Ophthalmic
- All makers of Syringe, Piston
- All makers of Laser, Ophthalmic
- All makers of Unit, Phacofragmentation
- All makers of Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Updated June 5, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.