Vortex Surgical recalled 14,789 units of its Lindsell Sutured IOL Marker on December 16, 2025. The recall stems from potential voids in the seal of Tyvek pouches, risking bioburden contamination. Healthcare providers and patients must stop using the device immediately.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Vortex Surgical Inc. or your healthcare provider for instructions. Notification method: Letter
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The Vortex Surgical Lindsell Sutured IOL Marker is used in ophthalmic surgeries to mark the position for intraocular lens placement. Surgeons rely on the sterility of this product to ensure patient safety during procedures.
Void seals in Tyvek pouches can lead to exposure to contaminants, increasing the risk of infection post-surgery. The integrity of the sterile barrier is critical in preventing surgical site infections.
This recall is not part of a broader industry pattern.
The recall may inconvenience healthcare providers and patients awaiting surgery, but it is essential for maintaining safety standards.
The catalog number and lot number can usually be found on the packaging or the product itself.
Expect a response regarding the recall process within 4-6 weeks.
Document all communications with the manufacturer, retain receipts, and keep a record of the product details.
The recalled product is the Vortex Surgical Lindsell Sutured IOL Marker, model VS0390. It is distributed worldwide, with 8,651 units in the US and 6,138 units outside the US.
Not sure what to do next? Our guide walks you through the process step by step.
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