FDA-Device2026-02-11Class IIPACKAGING DEFECT
Volk Single Use Vitrectomy Lenses recalled for compromised sterile packaging
Nationwide distribution
Stop using affected Volk vitrectomy lenses
Volk Surgical's single-use vitrectomy lenses (Flat Vitrectomy Lens and Volk Magnifying Lens) in certain lots may have voids or breaks in their Tyvek sterile pouches. A compromised sterile barrier can allow bacterial contamination, which could lead to infection during eye surgery.
- Check if you have the affected lots: Flat Vitrectomy Lens (lots 2410036, 2411020) or Volk Magnifying Lens (lot 2411019)
- Do not use affected lenses for any procedures
- Contact Volk Surgical or your distributor for replacement lenses or instructions
- If you already used an affected lens, contact your eye care provider
Hazard
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.
Sold states
Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.
Affected count
14,789 (8651 US; 6138 OUS)
Manufactured in
4 Research Park Dr Ste 124, N/A, Saint Charles, MO, United States
Products
Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1244-2026Don't want to check this manually?
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