FDA-Device2026-02-11Class IIPACKAGING DEFECT
Volk Single Use Vitrectomy Lenses recalled for compromised sterile packaging
Nationwide distributionMedical devices
What this means
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
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
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-1244-2026Want us to check the next one for you?
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