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

Catalog Number	8065751561
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	09/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that cutting and aspiration failure of the probe occurred during surgery.The surgery was completed after replacing the product with another one.There was no patient impact.The procedure type was unknown.
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
Additional information provided in d.9., h.3., h.6.And h.11.One opened probe with tip protector in a pouch was received for the report.The sample was visually inspected and found to be nonconforming with orange/brown foreign material on the port face and white/clear foreign material on the body needle.The sample was then functionally tested for aspiration, actuation, and cut.The sample was found to be nonconforming for aspiration, nonconforming for actuation, and conforming for cut.The probe was disassembled and the components inspected.Excessive wear observed on inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Gouge marks observed at bend area, cutting edge and several locations along the inner cutter.The sample was tested with a syringe and resistance was felt.A wire enters the aspiration path but does not go through.The sample was retested with a syringe, and resistance was felt.Solid material blocking the aspiration path.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 was unable to identify the root cause or origin of the reported event.Additionally, no manufacturing-related deficiencies were found that potentially could have contributed to the complaint.The complaint evaluation confirms the probe had an aspiration and actuation failure and does not confirm a cut failure.The root cause for the aspiration failure could not be determined as solid material was blocking the aspiration path.The root cause for the actuation failure is the observed gouge marks.The probe was disassembled, and the components inspected.The wear observed on inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos is consistent with excessive use classification.Excess usage of the probe will wear and damage the inner cutter such that the cutter function becomes poor, bent, or does not function at all.Per the direction for use (dfu), the vitrectomy probe is verified for 20 minutes of use at maximum cut speed.Excess usage will also introduce a greater amount of surgical material, increasing the likelihood of partial or full occlusion of the aspiration path.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time as the reported cut failure was not confirmed and the observed actuation and aspiration failures were due to excessive use of the probe by the user.Per the dfu, the vitrectomy probe is verified for 20 minutes of use at maximum cut speed.A nonconformance investigation has been 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: CONSTELLATION 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: 23381275
• Report Number: 1644019-2025-04281
• Device Sequence Number: 4940436
• Product Code: LRO
• UDI-Device Identifier: 00380657515615
• UDI-Public: (01)00380657515615(17)260930(11)241001(10)1730LM
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 8065751561
• Device Lot Number: 1730LM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 01/31/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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: CONSTELLATION VISION SYSTEM.
• Patient Sex: Unknown