Alcon Research, LTD. Constellation Procedure Pak Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Constellation Procedure Pak
Brand
Alcon Research, LTD.
Lot Codes / Batch Numbers
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, 15D649.
Products Sold
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, 15D649.
Alcon Research, LTD. is recalling Constellation Procedure Pak due to Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Recommended Action
Per FDA guidance
Customers were sent a Voluntary Medical Device Correction Notification by mail and dated 06/29/2023. Customers are asked to follow the risk mitigation precautions detailed in the notice to avoid the instance of overtightening the Phaco Tip and generating plastic particles. Additionally, customers are asked to forward the recall notification to all departments or organizations that use recalled devices. Customers are asked to complete and return the provided Response Form by fax at 817-302-4337 or email at Market.Actions@alcon.com. Customers who have experienced any adverse events or quality related issues are to contact alcon via email at msus.safety@alcon.com or by phone at 1-800-757-9780, Option 5.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026