medical Class II Updated 2026-02-11

Vortex Surgical Inc. recalls Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens

Recalled Product

Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD

Hazard / Issue

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 1. Flat Vitrectomy Lens Pouch UDI 810123482290 Box UDI 810123482306 Lots 2410036 2411020 2. Volk Magnifying Lens Pouch UDI 810123482825 Box UDI 810123482832 Lot 2411019
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