Alcon Constellation Procedure Pak recalled due to plastic debris risk
Alcon is recalling the Constellation Procedure Pak due to reports of patient injury from plastic debris. The debris can result from over-tightening the device 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: FDA Class II recall with reported patient injuries during device use. The plastic debris hazard from over-tightening poses direct harm that has been documented in patient reports.
Plain-English summary
Alcon Research, LTD. is recalling the Constellation Procedure Pak, a medical device used in surgical procedures. The recall affects approximately 10,580 units distributed worldwide, including throughout the United States.
The recall was initiated due to reports of patient injury during use of the device. The injury risk stems from the potential for plastic debris to be generated when the device is over-tightened using the included plastic wrench.
Patients and healthcare providers who have received or used this device should immediately cease further use and contact Alcon Research, LTD. for instructions on device return and replacement.
The recalled product
- Product
- Constellation Procedure Pak
- Manufacturer
- Alcon Research, LTD.
- Affected units
- 10,580
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. 8065750958
- Product Code 100007216
- UDI-DI: 380657509584
- Lots 14XM2J
- 14Y1H6
- 150HYJ
- 150HYK
- 151R72
- 152CH0
- 15309X
- 156HWN
- 15A13R
- 15A13T
- 15CF2X
- 15CF2Y
- 15CF30
- 15CJ47
- 15CJ48
- 15CWAM
- 15CWAN
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.
See all →- SeverePhaco Standalone Tips Recalled Due to Plastic Debris Risk
FDA (Devices) · 2023-08-23
- SevereAlcon Custom Pak Intraocular Lens Packages Recalled for Plastic Debris Risk
FDA (Devices) · 2023-08-23
- SevereLegion FMS Pak Surgical Instruments Recalled for Patient Injury from Plastic Debris
FDA (Devices) · 2023-08-23
- SevereInfinity FMS Pak surgical device recalled for plastic debris hazard
FDA (Devices) · 2023-08-23
- 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