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

Model Number 8065751761

Device Problems Defective Device (2588); Activation Failure (3270)

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

Event Date 01/16/2023

Event Type  malfunction  

Event Description

Writer was notified by the surgical technician who was working in the cataract procedure room that per protocol the phaco handpiece comes sterile with the i/a tip attached.The handpiece was attached to the phaco machine, tested and primed but malfunctioned.A new i/a tip was opened tested and passed without any additional issues.

• Brand Name: CENTURION OZIL HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 16536629
• MDR Text Key: 311226901
• Report Number: 16536629
• 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: 01/17/2023

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: 8065751761
• Device Catalogue Number: 8065751761
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1