MAUDE Adverse Event Report: Alcon Research, LLC - Houston UNITY TOTAL PLUS Posterior Procedure Pack; General surgery tray (kit)

Catalog Number	8065000478
Medical Device Problem Codes	Suction Problem (2170); Failure to Cut (2587)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that the vitrectome malfunctioned during surgery, as it failed to perform both cutting and vacuum functions.The procedure type was unknown.Even after reducing the cutting speed to 10000 cuts per minute (cpm) and changing the pump of the console the issue was not resolved.The procedure was able to continue after the affected vitrectome was replaced with a new one.It was unknown how the surgery was completed.There was no information about the patient impact.Additional information could not be obtained because the initial reporter declined further follow-up contact.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

• Brand Name: UNITY TOTAL PLUS Posterior Procedure Pack
• Common Device Name: General surgery tray (kit)
• Manufacturer (Section D): Alcon Research, LLC - Houston; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): Alcon Research, LLC - Houston; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; +1(800)757-9780
• MDR Report Key: 50934512
• Report Number: 1644019-2026-04990
• Device Sequence Number: 13159103
• Product Code: LRO
• UDI-Device Identifier: 00380650004789
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: Health Professional
• Device Catalogue Number: 8065000478
• Device Lot Number: 1832VC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 05/13/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown