United StatesMultiple single‑use ophthalmic devices distributed by Vortex Surgical Inc., including Volk Flat Vitrectomy Lens (Catalog VFD), Volk Magnifying Lens (Catalog VMD) and numerous Vortex and Oertli laser probes, forceps, cannulas, injection kits and convenience kits are affected; affected items are identified by the catalog numbers, UDIs and lots listed in the notice. They were recalled because voids were found in Tyvek pouch seals that compromise the sterile barrier and could allow contamination and infection.
What's being recalled
Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No. VS0130.25 4. 25GA Laser Probe Illuminated Curved Cat No. VS0125.25B 5. 25GA Laser Probe MaxReach Cat No. VS0140.25 6. 25GA Laser Probe Straight Cat No. VS0110.25
Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser Probe OS4 Intuitive Exendable VK401325 7. 27G Laser Probe OS4 Intuitive Exendable VK401327
Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8 Talon Forceps ILM VS0752.25 7. 25GA ACTU8 Talon Forceps Pro-Grip VS0751.25 8. 27GA ACTU8 Forceps ILM VS0744.27 9. 23GA Soft Tip Cannula VS0200.23 10. 23GA Soft Tip Cannula - 0.5mm VS0205.23 11. 25GA Soft Tip Cannula VS0200.25 12. 25GA Soft Tip Cannula - 0.5mm VS0205.25 13. 25GA Soft Tip Cannula - 0.5mm - Bulk VS0205.25B 14. 25GA Soft Tip Cannula-Bulk VS0200.25B 15. 27GA Soft Tip Cannula VS0200.27
25GA Subretinal Injection Cannula VS0220.25
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES
Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
Tecfen Retractable Membrane Polisher, QTPR1267-23
Vortex Surgical I2 Injection Kit, VS0500
Rumex Disposable Diamond Dusted ILM Elevator, 12-7523
Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
Recalling firm: Vortex Surgical Inc., Saint Charles, MO, United States.
How to identify it
1. Flat Vitrectomy Lens Pouch UDI 810123482290 Box UDI 810123482306 Lots 2410036 2411020 2. Volk Magnifying Lens Pouch UDI 810123482825 Box UDI 810123482832 Lot 2411019 1. 23GA Laser Probe Curved Pouch UDI 810123480036 Box UDI 810123480180 Lot 2411027 2. 25GA Laser Probe Curved Pouch UDI 810123480043 Box UDI 810123480197 Lot 2411026 3. 25GA Laser Probe Flex-Tip Pouch UDI 810123480111 Box UDI 810123480265 Lot 2411024 2411031 4. 25GA Laser Probe Illuminated Curved Pouch UDI 810123480098 Box UDI 810123480241 Lot 2411025 5. 25GA Laser Probe MaxReach Pouch UDI 810123480135 Box UDI 810123480289 Lot 2410029 2411023 6. 25GA Laser Probe Straight Pouch UDI 810123480012 Box UDI 810123480166 Lot 2411030 1. 23G Laser Probe OS4 Flex-Tip Pouch UDI 810123483716 Box UDI 810123483792 Lot 2410031 2. 23G Laser Probe OS4 Illuminated Flex-Tip Pouch UDI 810123483730 Box UDI 810123483815 Lot 2410034 3. 23G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483761 Box UDI 810123483846 Lot 2410033 4. 25G Laser Probe OS4 Flex-Tip Pouch UDI 810123483723 Box UDI 810123483808 Lot 2410032 2410058 2411022; 5. 25G Laser Probe OS4 Illuminated Flex-Tip Pouch UDI 810123483747 Box UDI 810123483822 Lot 2410035 6. 25G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483778 Box UDI 810123483853 Lot 2412025 7. 27G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483785 Box UDI 810123483860 Lot 2411021 1. 23GA ACTU8 Forceps Adaptive Pouch UDI 810123481125 Box UDI 810123481538 Lot 2411009 2. 25GA ACTU8 Forceps Adaptive Pouch UDI 810123481132 Box UDI 810123481545 Lot 2410051 3. 25GA ACTU8 Forceps ILM Pouch UDI 810123481231 Box UDI 810123481644 Lot 2410021 2410053 2411006 4. 25GA ACTU8 Forceps ILM -Myopic Pouch UDI 810123481248 Box UDI 810123481651 Lot 2410059 5. 25GA ACTU8 Forceps Pro-Grip Pouch UDI 810123481101 Box UDI 810123481514 Lot 2410050 2411011 6. 25GA ACTU8 Talon Forceps ILM Pouch UDI 810123481835 Box UDI 810123481859 Lot 2411003 7. 25GA ACTU8 Talon Forceps Pro-Grip Pouch UDI 810123482375…
The 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.
XXX
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)