FDA-Device2026-02-11Class IIPACKAGING DEFECT

Vortex Surgical Lindsell Sutured IOL Marker recalled for compromised sterile packaging

Nationwide distributionMedical devices

What this means

Vortex Surgical has recalled certain lots of the Lindsell Sutured IOL Marker (a scleral marker used in eye surgery) because the sterile Tyvek pouches may have small voids or openings in their seals. A compromised seal can allow bacteria to enter the package, which could contaminate the sterile device and lead to infection if used in surgery.

Stop using any Lindsell Sutured IOL Marker (VS0390) from lot 2408035.
Contact Vortex Surgical or your surgical supplier for instructions on how to return or safely dispose of affected units.
Check your inventory for the affected lot number and notify your hospital or clinic's quality or device management team.

The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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.

Affected count

14,789 (8651 US; 6138 OUS)

Manufactured in

4 Research Park Dr Ste 124, N/A, Saint Charles, MO, United States

Products

Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1256-2026

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