Vortex Surgical recalled 14,789 single-use vitrectomy lenses on December 16, 2025. The recall affects models with potential seal voids that could lead to bioburden contamination. Patients and healthcare providers must stop using these devices 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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Vitrectomy lenses are surgical devices used in eye surgeries to assist in procedures involving the retina and vitreous. Medical professionals purchase these lenses for their critical roles in delicate eye surgeries.
Compromised seals in the Tyvek pouches can lead to contamination, posing a significant health risk during surgeries. This increases the likelihood of infections that could severely affect patient outcomes.
This recall is not part of a broader industry pattern.
Patients and healthcare providers face potential health risks due to possible infections. The immediate cessation of use is necessary to mitigate this risk.
Look for the catalog number and lot number on the packaging of the vitrectomy lenses.
Expect a processing time of 4-6 weeks for refunds or replacements.
Keep records of purchase receipts, communications with the manufacturer, and any medical symptoms experienced.
The recall includes two models: Flat Vitrectomy Lens, Catalog VFD and Volk Magnifying Lens, Catalog VMD. The affected products were distributed in the U.S. and internationally, with specific lots identified for recall.
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