Class II U.S. Food and Drug Administration

D.O.R.C. Dutch Opthalmic Research Center Intl B.V. TDC Veloce" recall: An increase in incidence in complaints of a loose outer knife and reports

Recall published 4 months ago

An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2323-2026
Published
June 17, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Product type
Medical devices
Units affected
2068 boxes totaling 12408 units
Distribution
Nationwide
Made in
Netherlands
Lot / code info
1. Article Number: 9268.VIT25; UDI-DI: 08717872031873; 2. Article Number: 9311.25G01; UDI-DI: 08717872035116; 3. Article Number: 9311.25G02; UDI-DI: 08717872035345; 4. Article Number: 9311.25K01; UDI-DI: N/A; 5. Article Number: 9311.25K02; UDI-DI: N/A; 6. Article Number: 9311.25K03; UDI-DI: N/A; 7. Article Number: 9625.G0201; UDI-DI: N/A; Lot Numbers: 101118001, 101799001, 101800001, 102675001, 102676001, 103507001, 103508001, 103509001, 104360001, 50489-*-*-1, 54992-*-*-1, 54993-*-*-1, 54994-*-*-1, 56251-*-*-1, 56254-*-*-1, 56255-*-*-1, 56256-*-*-1, 56257-*-*-1, 57683-*-*-1, 58588-*-*-1, 58589-*-*-1, 60300-*-*-1, 65315-*-*-1, 65316-*-*-1, 65317-*-*-1, 65318-*-*-1, 65319-*-*-1, 65320-*-*-1, 65321-*-*-1, 65322-*-*-1, 66818-*-*-1, 70551-*-*-1, 70552-*-*-1, 70565-*-*-1, 70566-*-*-1, 70567-*-*-1, 71803-*-*-1, 71804-*-*-1, 71805-*-*-1, 71806-*-*-1, 75717-*-*-1, 76191-*-*-1, 76516-*-*-1, 76806-*-*-1, 76807-*-*-1, 76808-*-*-1, 76852-*-*-1, 76853-*-*-1, 76854-*-*-1, 76855-*-*-1, 77374-*-*-1, 77375-*-*-1, 77501-*-*-1, 77502-*-*-1, 77503-*-*-1, 77504-*-*-1, 77505-*-*-1, 78097-*-*-1, 78098-*-*-1, 78110-*-*-1, 78111-*-*-1, 79425-*-*-1, 79426-*-*-1, 81292-*-*-1, 81293-*-*-1, 81681-*-*-1, 82172-*-*-1, 82173-*-*-1, 82174-*-*-1, 82326-*-*-1, 82702-*-*-1, 82703-*-*-1, 82704-*-*-1, 82778-*-*-1, 83543-*-*-1, 83544-*-*-1, 84535-*-*-1, 84536-*-*-1, 84537-*-*-1, 85411001, 85412001, 86024001, 86025001, 86026001, 86806001, 86807001, 87173001, 87174001, 87175001, 87390001, 87950001, 88204001, 88205001, 88552001, 88616001, 89535001, 90377001, 90378001, 90379001, 91280001, 91281001, 92631001, 92633001, 95437001, 99667001;
UPC codes
08717872031873, 08717872035116, 08717872035345

Products covered by this recall

TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;

Check your product

The notice names 10 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 08717872031873
  • 08717872035116
  • 08717872035345

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 101118001
  • 101799001
  • 101800001
  • 102675001
  • 102676001
  • 103507001
  • 10350

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

D.O.R.C. Dutch Opthalmic Research Center Intl B.V. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: D.O.R.C. Dutch Opthalmic Research Center Intl B.V. — Scheijdelveweg 2, Zuidland

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was D.O.R.C. Dutch Opthalmic Research Center Intl B.V. medical… recalled?

An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use. An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 08717872031873, 08717872035116, 08717872035345; lot code 101118001, 101799001, 101800001. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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