Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
FDA Recall #Z-1256-2026 — Class II — December 16, 2025
Product Description
Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
Reason for Recall
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.
Recalling Firm
Vortex Surgical Inc. — Saint Charles, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
14,789 (8651 US; 6138 OUS)
Distribution
Worldwide Distribution: US (nationwide) to states of: 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, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.
Code Information
Pouch UDI 810123483655 Box UDI 810123483662 Lot 2408035
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated