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

Catalog Number	8065000478
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Intraocular Pressure Decreased (4468)
Date of Event	07/03/2026
Type of Reportable Event	Malfunction

• 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: 50032641
• Report Number: 1644019-2026-04003
• Device Sequence Number: 13387807
• Product Code: LRO
• UDI-Device Identifier: 00380650004789
• UDI-Public: (01)00380650004789(17)270630(11)250705(10)17J171
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: 17J171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/08/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 07/05/2025
• 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