Single use vitrectomy lenses recalled over voids in pouch seals
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
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: Scored 3 under the risk-of-harm criterion: the firm states a compromised sterile barrier could lead to infection, and no injuries are reported.
Plain-English summary
This recall by Vortex Surgical Inc. covers Volk Single Use Vitrectomy Lenses, covering the Flat Vitrectomy Lens (catalog VFD) and the Volk Magnifying Lens (catalog VMD).
The record states there may be voids located in the seal of Tyvek pouches associated with the identified catalog numbers and lots, and that a compromised sterile barrier has the potential of bioburden contamination which could lead to infection.
The record lists 14,789 units, of which 8,651 are in the US and 6,138 outside it, with pouch and box UDI codes and lot numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States across the states listed in the record. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should quarantine affected stock and follow Vortex Surgical's instructions.
The recalled product
- Product
- Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
- Manufacturer
- Vortex Surgical Inc.
- Hazard
- sterile-barrier
- pouch-seal
- infection-risk
Distribution
Distributed nationwide across the United States.
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