HIGHFDA DEVICE

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.

D.O.R.C. Dutch Opthalmic Research Center Intl B.V.Health & Personal CareMedical Devices1. Article Number: 9268.VIT27UDI-DI: 087178720318802. Article Number: 9311.27G01

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
April 30, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
April 30, 2026
Hazard Level
HIGH
Brand
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Model numbers
1. Article Number: 9268.VIT27, UDI-DI: 08717872031880, 2. Article Number: 9311.27G01, UDI-DI: 08717872035123, 3. Article Number: 9311.27G02, UDI-DI: 08717872035352, 4. Article Number: 9311.27K01, UDI-DI: N/A +8 more
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    April 30, 2026

  2. Reported by FDA DEVICE

    June 17, 2026

  3. RecallRadar source check

    June 23, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact D.O.R.C. Dutch Opthalmic Research Center Intl B.V. or your healthcare provider for instructions. Notification method: Letter

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Full Description

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;. Reason: An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.. Classification: Class II. Quantity: 261 boxes totaling 1566 units. Distribution: 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.

Safety Guide

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Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
1. Article Number: 9268.VIT27
UDI-DI: 08717872031880
2. Article Number: 9311.27G01
UDI-DI: 08717872035123
3. Article Number: 9311.27G02
+11 more
Affected States
ALL
Report Date
June 17, 2026
Recall Status
ACTIVE