FDA-Device2026-06-17Class IIPROCESSING DEFECT
D.O.R.C. TDC VELOCE 27G Two Dimensional Cutter recalled for loose outer knife
What this means
The outer knife on certain D.O.R.C. TDC VELOCE 27G surgical cutters may become loose during use. This surgical device is used in ophthalmic (eye) procedures, and a loose knife could affect device performance.
- Check your TDC VELOCE 27G cutter against the recalled article numbers and lot numbers listed
- Contact your device supplier or D.O.R.C. for instructions on inspection, repair, or replacement
- Do not use affected units until you have received guidance from the manufacturer
The agency's original wording
Hazard
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
261 boxes totaling 1566 units
Manufactured in
Scheijdelveweg 2, N/A, Zuidland, N/A, Netherlands
Products
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;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2324-2026Want us to check the next one for you?
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