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.
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: 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
- 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
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Same hazard · plastic debris
See all →- HighCrush Orange Soda Recalled Due to Plastic Foreign Material
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