MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON UNITY TOTAL PLUS COMBINED PROCEDURE PACK; GENERAL SURGERY TRAY (KIT)

Catalog Number	8065000484
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
Non-healthcare professional reported that trocar in the pack was damaged, with a lifted metal burr or edge on the blade before the vitrectomy surgery.The surgery was completed after replacing the product with new trocar.There was no patient impact.
Event or Problem Description
Upon further assessment, it has been confirmed that the trocar in pack damaged, had burr/edge protruding out was identified to be a trocar bent cannula issue.
Additional Manufacturer Narrative
Corrected information provided in b.2., b.5, h.2., and h.11.Upon further review following submission of the initial report, it has been confirmed that the reported burr was observed on the cannula and not on the blade.Based on current information available this event does not meet reporting criteria as per the applicable regulations.The reported event does not meet criteria for reporting as per applicable regulation.No further reports will be submitted under mfg.Report number: 1644019-2025-03133.The manufacturer internal reference number is: (b)(4).

• 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 ; 8007579780
• MDR Report Key: 22932221
• Report Number: 1644019-2025-03133
• Device Sequence Number: 15742421
• Product Code: LRO
• UDI-Device Identifier: 00380650004840
• UDI-Public: (01)00380650004840(17)270430(11)250513(10)17E3H1
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 12/17/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 8065000484
• Device Lot Number: 17E3H1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 12/17/2025
• Date Device Manufactured: 05/13/2025
• 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