MAUDE Adverse Event Report: ALCON / ALCON RESEARCH, LLC ALCON CENTURION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number CENTURION

Device Problems Inability to Irrigate (1337); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2021

Event Type  malfunction  

Event Description

Alcon centurion vision system failed to provide aspiration and irrigation for the surgeon during a phaco procedure.Resulting in the surgeon having to complete the procedure using manual irrigation.Fda safety report id# (b)(4).

• Brand Name: ALCON CENTURION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON / ALCON RESEARCH, LLC
• MDR Report Key: 11364773
• MDR Text Key: 233276847
• Report Number: MW5099531
• Device Sequence Number: 1
• Product Code: HQC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2021

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 Model Number: CENTURION
• Device Catalogue Number: 215-0000-501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR