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

Catalog Number	8065000331
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/14/2025
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
A customer reported that the tip of the probe was bent before vitrectomy surgery.The surgery was completed on the same day, and it was unknown how the procedure was completed.There was no information about patient impact.
Additional Manufacturer Narrative
Based on the information received following the submission of the initial report, the bent tip of the probe (needle) was not considered a reportable malfunction, and recurrence is unlikely to result in serious injury.No further reports will be submitted under mfg report num.1644019-2025-03274.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 ; 8007579780
• MDR Report Key: 22993752
• Report Number: 1644019-2025-03274
• Device Sequence Number: 9619579
• Product Code: LRO
• UDI-Device Identifier: 00380650003317
• UDI-Public: (01)00380650003317(17)270430(11)250512(10)17E3H7
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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: 8065000331
• Device Lot Number: 17E3H7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/30/2025
• Date Device Manufactured: 05/12/2025
• 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