MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number TABLETOP

Device Problems Intermittent Continuity (1121); Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported the system shutdown during a retinal surgical procedure following 5 system messages.The system was rebooted to complete the procedure with no harm to the patient.

Manufacturer Narrative

The customer called the company representative to assist with troubleshooting.The footswitch was determined to have been the cause the issue.The customer was able to resolve the issue remotely, by ordering a new footswitch.The footswitch was manufactured on april 30, 2012.Based on qa assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 8276079
• MDR Text Key: 134072618
• Report Number: 2028159-2019-00136
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/09/2019

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: TABLETOP
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 01/24/2019
• Supplement Dates Manufacturer Received: 04/03/2019
• Supplement Dates FDA Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1