TDC VELOCE 25 gauge vitrectomy cutters may have loose outer knife
TDC VELOCE 25G Two Dimensional Cutters are being recalled following an increase in complaints of a loose outer knife, including reports of it loosening during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where a cutting component may loosen during an eye procedure, a risk of harm with no injuries reported in the source.
Plain-English summary
The TDC VELOCE 25G Two Dimensional Cutter - 20k CPM, from D.O.R.C. Dutch Ophthalmic Research Center Intl B.V., is being recalled across article numbers 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03 and 9625.G0201. The action covers 2,068 boxes totalling 12,408 units.
The stated reason is an increase in the incidence of complaints of a loose outer knife, with reports of the outer knife becoming loose during use. The FDA classified the action as Class II.
Affected lot numbers are 101118001, 101799001, 101800001 and 102675001. Distribution was worldwide, including nationwide in the United States and to Australia, Austria, Belgium, Bulgaria, Czechia, Finland, France, Germany, Great Britain, Hong Kong, Ireland, Italy, Japan, the Netherlands, New Zealand, Poland, Slovenia, South Africa, Spain, Sweden, Taiwan and Turkey.
Facilities should identify affected stock using the article numbers, UDI-DI codes and lot numbers above, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;
- Manufacturer
- D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
- Hazard
- component-loosening
- outer-knife
- ophthalmic-surgery
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1. Article Number: 9268.VIT25
- UDI-DI: 08717872031873
- 2. Article Number: 9311.25G01
- UDI-DI: 08717872035116
- 3. Article Number: 9311.25G02
- UDI-DI: 08717872035345
- 4. Article Number: 9311.25K01
- UDI-DI: N/A
- 5. Article Number: 9311.25K02
- 6. Article Number: 9311.25K03
- 7. Article Number: 9625.G0201
- Lot Numbers: 101118001
- 101799001
- 101800001
- 102675001
- 102676001
- 103507001
- 103508001
- 103509001
- 104360001
Distribution
Distributed nationwide across the United States.
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