CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report

TDC Veloce" Two Dimensional Cutter - 20k CPM recalled

D.O.R.C. Dutch Opthalmic Research Center Intl B.V is recalling TDC Veloce" Two Dimensional Cutter - 20k CPM, distributed nationwide in the US. The recall was initiated on 30 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. 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;

Quantity recalled2068 boxes totaling 12408 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2323-2026
FDA event ID: 98814
Recalling firm: D.O.R.C. Dutch Opthalmic Research Center Intl B.V, Zuidland, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 30 Apr 2026
FDA classified: 5 Jun 2026
Reported: 17 Jun 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

30 Apr 2026	Recall initiated by company
5 Jun 2026	Classified by FDA	+36 days
17 Jun 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

Worldwide - US Nationwide and the countries of AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, CZECHIA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, HONG KONG, IRELAND, ITALY, JAPAN, NETHERLANDS, NEW ZEALAND, POLAND, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, TURKEY.

Nationwide

Questions about this recall

Is TDC Veloce" Two Dimensional Cutter - 20k CPM recalled?

Yes. D.O.R.C. Dutch Opthalmic Research Center Intl B.V recalled TDC Veloce" Two Dimensional Cutter - 20k CPM on 30 Apr 2026. The recall is Class II and its status is Ongoing. Recall number Z-2323-2026.

Why was it recalled?

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

Which lots are affected?

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;

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from D.O.R.C. Dutch Opthalmic Research Center Intl B.V

All 6

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Device	CLASS II	TDC Veloce" Two Dimensional Cutter - 20k CPM recalled	D.O.R.C. Dutch Opthalmic Research Center Intl B.V	Other	Nationwide
17 Jun 2026Device	CLASS II	TDC Veloce" Two Dimensional Cutter - 20k CPM recalled	D.O.R.C. Dutch Opthalmic Research Center Intl B.V	Other	Nationwide
27 Mar 2024Device	CLASS II	Directional Laser Probe with Alcon / Lumenis connector recalled	D.O.R.C. Dutch Opthalmic Research Center Intl B.V	Other	Nationwide
27 Mar 2024Device	CLASS II	Directional Laser Probe with Alcon / Lumenis connector recalled	D.O.R.C. Dutch Opthalmic Research Center Intl B.V	Other	Nationwide
27 Mar 2024Device	CLASS II	Directional Laser Probe with Alcon / Lumenis connector recalled	D.O.R.C. Dutch Opthalmic Research Center Intl B.V	Other	Nationwide

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