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

Model Number	8065751014
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The syringe (auto gas fill pak) was hooked up to the constellation system and "auto fill" button was pressed.The syringe did not fill as anticipated.A new pak was opened and used.

• Brand Name: ALCON
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 10520718
• Report Number: 10520718
• Device Sequence Number: 3155615
• Product Code: HQC
• UDI-Device Identifier: 00380657510146
• UDI-Public: (01)00380657510146
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2020
• Report Date (Section F): 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8065751014
• Device Catalogue Number: 8065751014
• Device Lot Number: 2368473H
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 09/11/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/24/2020