The Recall Desk
SevereFDA (Devices)·Z-2408-2023·Announced 2023-08-23

Infinity FMS Pak surgical device recalled for plastic debris hazard

Alcon is recalling the Infinity FMS Pak surgical device after reports of patient injuries during procedures caused by plastic debris from over-tightening the included wrench. The recall affects 51,054 units distributed worldwide.

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: FDA Class II recall with documented patient injuries reported during procedures. The presence of actual injury incidents meets the Score 4 criterion for significant injury reports.

Plain-English summary

Alcon Research, LTD. is recalling 51,054 units of the Infinity FMS Pak surgical device. The recall was initiated after reports of patient injuries during procedures. These injuries resulted from plastic debris created when the device was over-tightened with the included plastic wrench.

The risk stems from the wrench design: over-tightening can cause plastic components to break down and shed small particles. During surgical procedures, these debris particles posed a risk of patient injury.

The device was distributed worldwide, including throughout the United States and to numerous countries. Alcon has identified specific lot numbers and product codes associated with this recall.

The recalled product

Product
Infinity FMS Pak
Manufacturer
Alcon Research, LTD.
Category
Medical Device
Hazard
Affected units
51,054

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 (20)

  • Catalog No. 8065741085
  • 8065750280
  • 8065750281
  • 8065752086
  • 8065752087
  • 8065752090
  • 8065752093
  • 8065752094
  • 8065752095
  • 8065752096
  • Product Code 100003158
  • 100004405
  • 100055054
  • 100009758
  • 100009094
  • 100009370
  • 100009098
  • 100009099
  • 100009100
  • 100009101

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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