MAUDE Adverse Event Report: ALCON LABORATORIES, INC. CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number 0981

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 07/20/2022

Event Type  malfunction  

Event Description

During the vitrectomy performed on the patient, the alcon constellation vision system being used malfunctioned.After troubleshooting, it was determined that the system would need to be swapped with another system.The process of troubleshooting and setting up the new system caused about a twenty-minute delay of procedure.The equipment that malfunctioned has been isolated and designated for repair.The specific issue is that the equipment malfunctioned when switching from infusion to air.

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 15128430
• MDR Text Key: 296846924
• Report Number: 15128430
• 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: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 0981
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15695 DA
• Patient Sex: Female