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

Catalog Number	8065000485
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction

• Brand Name: UNITY TOTAL PLUS Combined 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: 50339421
• Report Number: 1644019-2026-04404
• Device Sequence Number: 5469241
• Product Code: LRO
• UDI-Device Identifier: 00380650004857
• UDI-Public: (01)00380650004857(17)271231(11)260123(10)17VW89
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 10/02/2026

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: 8065000485
• Device Lot Number: 17VW89
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 01/23/2026
• 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 Age: 58 YR
• Patient Sex: Male