The Recall Desk
SevereFDA (Devices)·Z-2409-2023·Announced 2023-08-23

Legion FMS Pak Surgical Instruments Recalled for Patient Injury from Plastic Debris

Alcon is recalling Legion FMS Pak surgical instruments due to reports of patient injuries caused by plastic debris generated from over-tightening with the included plastic wrench.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This FDA Class II medical device recall involves reported patient injuries during surgical procedures. Actual harm has been documented, elevating this beyond theoretical risk to confirmed incidents requiring a Severe rating.

Plain-English summary

Alcon Research, LTD. is recalling the Legion FMS Pak surgical instruments worldwide due to a hazard involving plastic debris. Reports indicate that patient injuries have occurred during procedures when the device is over-tightened with the included plastic wrench, which can generate plastic debris.

The recall affects 2,628 units that were distributed throughout the United States and to numerous countries worldwide. The affected product codes and lot numbers have been identified by the manufacturer.

Healthcare providers and patients using this product should discontinue use immediately. Anyone who has experienced injury or complications related to this device should contact their healthcare provider.

The recalled product

Product
Legion FMS Pak
Manufacturer
Alcon Research, LTD.
Category
Medical Device
Hazard
Affected units
2,628

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • Catalog No. 8065753164
  • 8065753165
  • 8065753166
  • Product Code 100205822
  • 100207728
  • 100207729
  • UDI-DI: 380657531646
  • 380657531653
  • 380657531660
  • Lots 14YTR7
  • 153UW1
  • 156YMH
  • 157R2M.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Alcon Research, LTD. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Alcon Research, LTD.

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Same hazard · plastic debris

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