Vortex Surgical recalls Lindsell Sutured IOL Marker (VS0390) due to potential voids in Tyvek pouch seals that could cause infection. Affected units have specific catalog numbers and lots.
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 its Lindsell Sutured IOL Marker (VS039:0) because flaws in the sterile pouch seals might allow contamination. This could lead to infections if the marker is used in eye surgery.
The Tyvek pouches that hold the marker's sterile components may have small holes. If these holes allow bacteria to enter, it could cause infections during eye surgery.
Surgical professionals and patients who use the Lindsell Sutured IOL Marker for eye procedures. Those with the specific catalog numbers and lots listed are most at risk.
Check the pouch UDI code on the marker (810123483655) and the box UDI code (810123483662). The lot number 2408035 is also associated with this recall.
Look for the pouch UDI code 810123483655 and box UDI code 810123483662 on the marker packaging.
The recall states that the pouch seals may have voids that could lead to infection, so it is not safe to use without checking the recall details.
The recall does not specify a remedy, so you should check the product details and contact Vortex Surgical for further instructions.
Affected products have the pouch UDI code 810123483655, box UDI code 810123483662, and lot number 2408035.
We’ve drafted a message you can send Vortex Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1256-2026 — Vortex Surgical Vortex Surgical Hello, I own a Vortex Surgical that is covered by recall Z-1256-2026 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.
