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

Catalog Number	8065000383
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that when a trocar blade was inserted into a patient's eye, the trocar could not be held in the eye and it was not released from the blade when the trocar blade was pulled out of the eye, it came out with the trocar on during vitrectomy surgery.The product was replaced to complete the surgery.There was no information about patient impact.
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).
Additional Manufacturer Narrative
Corrected information provided in b.2.And h.11.Upon receipt of additional information, following submission of the initial report, it has been confirmed that there was no blade (trocar) issue and the blade was stuck into the trocar resulting in product fitting problem.Based on current information available this event does not meet reporting criteria as per the applicable regulations.No further reports will be scheduled under mfg report num.1644019-2025-04417 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: 23448669
• Report Number: 1644019-2025-04417
• Device Sequence Number: 13021790
• Product Code: LRO
• UDI-Device Identifier: 00380650003836
• UDI-Public: (01)00380650003836(17)270430(11)250522(10)17E3EX
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065000383
• Device Lot Number: 17E3EX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 02/09/2026
• Date Device Manufactured: 05/22/2025
• 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