Vortex Surgical Recalls Lindsell Sutured IOL Markers Over Sterility Concerns

What Happened

Vortex Surgical Inc. has initiated a voluntary recall of the Lindsell Sutured IOL Marker (Scleral Marker) due to a potential defect in the product’s packaging. The firm discovered that there may be voids in the seal of the Tyvek pouches used for the devices. A compromised sterile barrier increases the risk of bioburden contamination, which could lead to serious infections in patients.

Which Products Are Affected

The recall affects the following medical device:

• Product Name: Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
• Recall Number: Z-1256-2026
• Lot Number: 2408035
• UDI Numbers: Pouch UDI 810123483655; Box UDI 810123483662
• Quantity: 14,789 units total (8,651 in the U.S.; 6,138 internationally)

The product was distributed worldwide, including the following U.S. states: 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, and VA.

What You Should Do

Healthcare providers and facilities should immediately check their inventory for the affected lot number (2408035). Affected products should be quarantined and not used in surgical procedures. Vortex Surgical Inc. notified customers of the issue via a notification letter. For questions regarding returns or replacements, contact Vortex Surgical Inc. at 4 Research Park Dr Ste 124, Saint Charles, MO 63304.

Why This Matters

Maintaining a sterile barrier is critical for surgical instruments. Any breach in packaging integrity can introduce bacteria or other contaminants, posing a significant health risk to patients undergoing ophthalmic procedures.

Source

Information provided by the FDA.