MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PACK; GENERAL SURGERY TRAY (KIT)

Catalog Number	8065000096
Medical Device Problem Codes	Suction Problem (2170); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
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 vitrector stopped functioning, an attempt was made to check the cutter, significantly reduced aspiration was observed along the entire length of the tubing, as well as slowed, improper cutter performance during vitrectomy surgery.The vitrector was replaced using an additional cassette; however, the problem with proper cutter function occurred again.The surgery was completed on the same day with a second surgical set was opened, and the cassette together with the cutter was replaced.There was no impact to the patient.
Additional Manufacturer Narrative
Additional information provided in h.6.And h.11.No technical inquiries were received from the customer.A sample was not received at the manufacturing site for evaluation for the report.Therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The investigation conducted a nonconformance review of the reported lot.A nonconformance was found.This non-conformance could have potentially contributed to the reported event.Three non-conformance records were initiated to trend the defect of inner cutter rotational orientation non-conforming, one non-conformance was completed for inner cutter rotational orientation, 3 non-conformance records were initiated to trend the defect of excessive adhesive at cutter/coupling, one non-conformance record was initiated for spacer short shot, one non-conformance record was initiated to trend the defect of cut failure, and one non-conformance record was initiated to trend the defect of excessive adhesive at diaphragm/extension.Based on the evaluation of the information and materials received, the investigation was unable to identify the root cause or origin of the reported event.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time.A nonconformance investigation has been completed to investigate the trend identified for probes with would not cut or actuate issues.A non-conformance record has been completed in relation to the related non-conformances identified within the non-conformance review.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.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.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: CONSTELLATION SURGICAL 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: 24398461
• Report Number: 1644019-2026-01008
• Device Sequence Number: 9748177
• Product Code: LRO
• UDI-Device Identifier: 00380650000965
• UDI-Public: (01)00380650000965(17)270131(11)250217(10)178DF4
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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: 8065000096
• Device Lot Number: 178DF4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 05/20/2026
• Date Device Manufactured: 02/17/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CUSTOM-PAK SURGICAL PROCEDURE PACK.
• Patient Age: 72 YR
• Patient Sex: Female