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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- 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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- HighCenturion FMS Pak Recalled Due to Patient Injury Risk from Plastic Debris
FDA (Devices) · 2023-08-23
Same hazard · plastic debris
See all →- HighCrush Orange Soda Recalled Due to Plastic Foreign Material
FDA (Food) · 2023-11-08
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