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

Catalog Number	8065752452
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
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 the cutting failure of the probe occurred and the cutter was not sharp enough during vitrectomy surgery.The surgery was completed after replacing the product with another one.There was no impact to the patient.
Additional Manufacturer Narrative
No technical inquiries were received from the customer.One opened probe, with tip protector with a cut out tray label in a bag was received.The returned sample was visually inspected and was found to be nonconforming as the needle is slightly bent and orange/brown foreign material was observed on the welded cap.The sample was then functionally tested for actuation and cut.The sample was found to be nonconforming for actuation and cut.The probe was disassembled and the components inspected.Nominal wear observed on inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Inner cutter was bent.Gouge marks observed at the bend area and one another location on the inner cutter.A review of the device history record traceable to the lot number obtained from the device¿s radio frequency identification 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 a cut failure and indicated an actuation failure.The most likely cause for the actuation and cut failure is from the bent needle and bent inner cutter.A bent needle can impede the movement of the cutter shaft.This interference is present as observed from visual condition of the inner cutter.The exact root cause of the bent needle and bent inner cutter cannot be determined from this evaluation.The most likely root cause is handling at any point after the probe was shipped from the manufacturing site including use during surgery.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time as an exact root cause for an actuation and cut failure, bent needle and the bent inner cutter could not be determined from this evaluation.A nonconformance investigation is currently in progress 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 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: 22213426
• Report Number: 1644019-2025-01883
• Device Sequence Number: 20872509
• Product Code: LRO
• UDI-Device Identifier: 00380657524525
• UDI-Public: (01)00380657524525(17)260630(11)240719(10)16Y10U
• 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): 10/17/2025

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: 06/30/2026
• Device Catalogue Number: 8065752452
• Device Lot Number: 16Y10U
• 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: 05/27/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2024
• 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