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;
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
The hazard
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
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;
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1. Article Number: 9268.VIT23Model UDI-DI: 08717872031866Model 2. Article Number: 9311.23G01Model UDI-DI: 08717872035109Model 3. Article Number: 9311.23G02Model UDI-DI: 08717872035338Model 4. Article Number: 9311.23K01Model UDI-DI: N/AModel 5. Article Number: 9311.23K02Model 6. Article Number: 9311.23K03Model 7. Article Number: 9623.G0201Model 8. Article Number: 9623.G0202Model 9. Article Number: 9623.K0201Model 10. Article Number: 9311.23G01-00Model UDI-DI: 08717872035307Model Lot Numbers: 100637001Model 57682-*-*-1Model 64312-*-*-1Model 69017-*-*-1Model 73237-*-*-1UPC 08717872031866UPC 08717872035109UPC 08717872035338UPC 08717872035307Would you have heard about this one?
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