MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON UNITY ANTERIOR VITRECTOMY PACK; GENERAL SURGERY TRAY (KIT)

Catalog Number	8065753168
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/30/2025
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 physician reported that actuation issue of the cutter during cataract surgery with intraocular lens implant.The surgery was completed on the same day, and it was unknown how it got completed.There was no patient impact reported.
Additional Manufacturer Narrative
Additional information provided in d.9., h.2., h.3., h.6.And h.11.No technical inquiries were received from the customer.One opened probe with tip protector in a pouch was received for the report.The sample was visually inspected and found to be conforming.The sample was then functionally tested for actuation.The sample was found to be conforming.The probe engine was disassembled, and the components were inspected.The diaphragm, spacer, top o-ring are all intact.It was observed the o-rings have damage.A review of the device history record traceable to the lot number obtained from the device¿s radio frequency identification (rfid) tag, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The investigation conducted a non-conformance review of the reported lot number.No deviations were identified, and all corresponding production release specifications defined in the device master record were met.Based on the evaluation of the information and materials received, the investigation concluded that the root cause of the reported event is not determined as the returned sample was conforming for all functional testing.However, a manufacturing related potential contributor factor was identified, damaged was observed on the o-ring and cannot be ruled out for the actuation problem as reported.The returned sample functionally met specifications: however, a non-conformance was completed for the damage observed on the o-ring.A nonconformance investigation was completed to investigate the trend identified for probes with would not cut or actuate issues.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.Complaint data for all company products is reviewed monthly to monitor for adverse trends.During the last review, adverse trends were observed for the reported product and event combination.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No further action warranted at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: UNITY ANTERIOR VITRECTOMY 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: 23664036
• Report Number: 1644019-2025-05099
• Device Sequence Number: 21058193
• Product Code: LRO
• UDI-Device Identifier: 00380657531684
• UDI-Public: (01)00380657531684(17)270331(11)250421(10)17CMKL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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: 8065753168
• Device Lot Number: 17CMKL
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• 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