Vortex Surgical recalls two types of single-use vitrectomy lenses due to potential voids in Tyvek pouch seals that could cause infection. Affected items include specific catalog numbers and lots sold in 2024.
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.
Vortex Surgical is recalling flat vitrectomy lenses and magnifying lenses that may have voids in their Tyvek pouch seals. This could allow contamination and infection if the lenses are used without a proper sterile barrier.
The Tyvek pouches that hold the lenses may have small holes or gaps in the seal. This could let bacteria or other contaminants enter the sterile lens, increasing the risk of infection during surgery.
Surgical professionals using Volk Single Use Vitrectomy Lenses with catalog numbers VFD or VMD are likely affected. Patients undergoing eye surgery using these lenses face the risk of infection.
Check for catalog numbers VFD (flat lens) or VMD (magnifying lens) on the product. Affected items were sold with specific lot numbers: 2410036, 2411020, and 2411019.
Look for catalog numbers VFD or VMD on the lenses and associated lot numbers 2410036, 2411020, or 2411019.
The recall is due to potential voids in the Tyvek pouch seals that could lead to bioburden contamination and infection risk during surgery.
Check for catalog numbers VFD (flat lens) or VMD (magnifying lens) and lot numbers 2410036, 2411020, or 2411019.
The recall record does not specify a remedy, so affected users should contact Vortex Surgical directly for guidance.
We’ve drafted a message you can send Vortex Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1244-2026 — Vortex Surgical Vortex Surgical Hello, I own a Vortex Surgical that is covered by recall Z-1244-2026 from Vortex Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
