MAUDE Adverse Event Report: ALCON RESEARCH, LLC CENTURION PHACO MACHINE; UNIT, PHACOFRAGMENTATION

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 06/22/2022

Event Description

Centurion machine froze while in use and had to be rebooted.Fda safety report id# (b)(4).

• Brand Name: CENTURION PHACO MACHINE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 14957136
• MDR Text Key: 295609583
• Report Number: MW5110746
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White