MAUDE Adverse Event Report: ALCON LABORATORIES, INC. CONSTELLATION, EDGE PLUS, TOTAL PLUS, ULTRAVIT; VITRECTOMY, INSTRUMENT CUTTER

Model Number	8065752435
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Cutter in pack sluggish - not working properly.

• Brand Name: CONSTELLATION, EDGE PLUS, TOTAL PLUS, ULTRAVIT
• Common Device Name: VITRECTOMY, INSTRUMENT CUTTER
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 23424776
• Report Number: 23424776
• Device Sequence Number: 20893705
• Product Code: MLZ
• UDI-Device Identifier: 00380657524358
• UDI-Public: (01)00380657524358
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2025
• Report Date (Section F): 10/15/2025

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 Model Number: 8065752435
• Device Catalogue Number: 8065752435
• Device Lot Number: 17EEHM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 4 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 10/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/15/2025