MAUDE Adverse Event Report: ALCON RESEARCH, LLC CENTURION ACT ULTRA BAL 45; UNIT, PHACOFRAGMENTATION

Lot Number 153DKY

Device Problems Fluid/Blood Leak (1250); Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 11/14/2022

Event Type  malfunction  

Event Description

Pack contains phaco tubing centurion act ultra bal 45.Surgical technician was setting up and fluid was leaking all over the phaco machine and it was noted that the bag from the tubing was missing.Item was removed and a new phaco pack was opened up and case proceeded in a normal sterile fashion.

• Brand Name: CENTURION ACT ULTRA BAL 45
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC; 6201 south freeway; forth worth TX 76134
• MDR Report Key: 16408689
• MDR Text Key: 309888123
• Report Number: 16408689
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 153DKY
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Sex: Female