MAUDE Adverse Event Report: ALCON LABORATORIES, INC. CENTURION PHACO; UNIT, PHACOFRAGMENTATION

Model Number 0

Device Problem Overheating of Device (1437)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 04/08/2021

Event Type  malfunction  

Event Description

Phaco machine was getting too hot on phaco tip causing minor complications.Patient had a burn to the inside of they eye.

• Brand Name: CENTURION PHACO
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 11831192
• MDR Text Key: 250814421
• Report Number: 11831192
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1