FDA recall Z-2322-2026

D.O.R.C. Dutch Opthalmic Research Center Intl B.V. · Class II · device

Product

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;

Reason for recall

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

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.

Key facts

Status
Ongoing
Initiation date
2026-04-30
Report date
2026-06-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Zuidland, N/A, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2322-2026