MAUDE Adverse Event Report: ALCON RESEARCH, LTD INFINITI VISION SYSTEM TURBOSONIC MICRO TIP; APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED

Model Number 8065750159

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2016

Event Type  malfunction  

Event Description

During a cataract extraction surgery, the phaco tip being used on the piece of equipment broke off in the patient's eye.The surgeon was able to retrieve it and it did not cause harm to the patient.

• Brand Name: INFINITI VISION SYSTEM TURBOSONIC MICRO TIP
• Type of Device: APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED
• Manufacturer (Section D): ALCON RESEARCH, LTD; 714 columbia avenue; sinking spring PA 19608
• MDR Report Key: 5510000
• MDR Text Key: 40652883
• Report Number: 5510000
• Device Sequence Number: 1
• Product Code: HQR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2016,03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 8065750159
• Device Lot Number: 1429909H
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/04/2016
• Device Age: 1 DY
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 03/04/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 73