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

Model Number	8065753106
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Vitrectomy probe would not connect to the constellation machine when plugged in.The connector light would not turn green on the constellation machine.Probe was replaced prior to beginning surgery.

• Brand Name: CONSTELLATION® HYPERVIT® TOTAL PLUS®
• Common Device Name: VITRECTOMY, INSTRUMENT CUTTER
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway (r9-2); fort worth TX 76134
• MDR Report Key: 25428498
• Report Number: 25428498
• Device Sequence Number: 21413194
• Product Code: MLZ
• UDI-Device Identifier: 00380657531066
• UDI-Public: (01)00380657531066
• 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): 05/21/2026
• Report Date (Section F): 05/22/2026

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
• Operator of Device: Other
• Device Model Number: 8065753106
• Device Catalogue Number: 8065753106
• Device Lot Number: 17UCMD
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 06/08/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/22/2026