MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CENTURION ULTRAVIT PROBE PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number	8065752134
Medical Device Problem Codes	Break (1069); Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
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 healthcare professional reported that the vitrectomy probe suddenly burst and broke into two pieces during the vitrectomy surgery.The surgery details were unknown.There was no patient impact.Additional information requested and received that the weird noise had come from probe.The surgery was completed by replacing the probe.The surgeon promptly withdrew broken part of probe from the eye.
Event or Problem Description
Additional information received clarifying that the probe body was found separated.No patient harm occurred.
Additional Manufacturer Narrative
Additional information provided in b.2., b.5.And h.11.Upon review of the additional information received, it was clarified that the probe body was found to be separated.The event has does not meet the criteria for a reportable malfunction.There were no associated patient harm and recurrence of this is not expected to result in any serious injury.No further reports will be scheduled under mfg.Report num.1644019-2025-04612.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION ULTRAVIT PROBE PROCEDURE PAK
• 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: 23507829
• Report Number: 1644019-2025-04612
• Device Sequence Number: 12987762
• Product Code: LRO
• UDI-Device Identifier: 00380657521340
• UDI-Public: (01)00380657521340(17)251031(11)231115(10)169WN4
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/07/2026

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 8065752134
• Device Lot Number: 169WN4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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