FDA DeviceClass IINotable

FDA Recall: TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27

Date: 2026-06-17
Brand: D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Category: Medical Device
FDA Class: Class II

Description

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

Hazard

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

Remedy

261 boxes totaling 1566 units

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Related Recalls

2026-06-17 · FDA_DEVICE
FDA Recall: TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
2026-06-17 · FDA_DEVICE
FDA Recall: TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01, 9311.23
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