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

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

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-2322-2026
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
314 boxes, totaling 1884 units
Distribution
Nationwide
Made in
Netherlands
Lot / code info
1. Article Number: 9268.VIT23; UDI-DI: 08717872031866; 2. Article Number: 9311.23G01; UDI-DI: 08717872035109; 3. Article Number: 9311.23G02; UDI-DI: 08717872035338; 4. Article Number: 9311.23K01; UDI-DI: N/A; 5. Article Number: 9311.23K02; UDI-DI: N/A; 6. Article Number: 9311.23K03; UDI-DI: N/A; 7. Article Number: 9623.G0201; UDI-DI: N/A; 8. Article Number: 9623.G0202; UDI-DI: N/A; 9. Article Number: 9623.K0201; UDI-DI: N/A; 10. Article Number: 9311.23G01-00; UDI-DI: 08717872035307; Lot Numbers: 100637001, 57682-*-*-1, 64312-*-*-1, 69017-*-*-1, 73237-*-*-1, 74225-*-*-1, 75735-*-*-1, 79460-*-*-1, 80338-*-*-1, 80963-*-*-1, 81335-*-*-1, 81679-*-*-1, 82213-*-*-1, 82325-*-*-1, 82742-*-*-1, 82779-*-*-1, 83584-*-*-1, 84580-*-*-1, 85451001, 86069001, 86798001, 86799001, 87205001, 88231001, 91957001, 92629001, 92630001, 93336001, 94351001, 95436001, 95462001, 96097001, 96123001, 97279001, 97789001, 98643001, 99130001, 99185001, 99697001;
UPC codes
08717872031866, 08717872035109, 08717872035338, 08717872035307

Products covered by this recall

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;

Check your product

The notice names 6 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.

  • 08717872031866
  • 08717872035109
  • 08717872035338
  • 08717872035307

Lot or batch code

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

  • 100637001
  • 57682

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. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  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.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

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 08717872031866, 08717872035109, 08717872035338; lot code 100637001, 57682. 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?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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