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

Catalog Number	8065752436
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that although the priming of the pak was successful, when starting the pars plana vitrectomy surgery, the cutter/probe was not working efficiently (reduced cut rate) resulting in poor cutting of the vit probe.The aspiration was normal through out.The surgical team replaced the pack with a new one which primed successfully and the surgery was completed on the same day.There was no patient contact with the suspect product.This report pertains to vitrectomy probe involved in reported events.
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
No technical inquiries were received from the customer.One opened 23 gauze vitrectomy probe without tip protector in a tray was received for the report.The sample was visually inspected and found to be conforming.The sample was then functionally tested for actuation and cut.The sample was found to be conforming for all functional tests.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 lot number obtained from the device¿s rfid tag.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 visual and functional testing.No further investigative or manufacturing actions are warranted at this time due to that the returned sample met specifications.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.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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Corrected information provided in h.6.[imdrf (international medical device regulators forum) health impact code updated].The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Corrected information provided in b.5., d.9.And h.11.No technical inquiries were received from the customer.One opened probe with tip protector in a zip bag was received for the report.The sample was visually inspected and found to be non-conforming with orange/brown foreign material on the port face and welded cap and white foreign material on the needle.The sample was then functionally tested for actuation and cut.The sample was found to be conforming for all functional tests.One opened probe without tip protector in a tray was received for the report.The sample was visually inspected and found to be conforming.The sample was then functionally tested for actuation and cut.The sample was found to be conforming for all functional tests.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 lot number obtained from the device¿s rfid tag.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.No further investigative or manufacturing actions are warranted at this time due to that the returned sample met specifications.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.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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
Additional information was received that there was patient contact, but no impact to the left eye of the female adult patient.

• 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: 23390504
• Report Number: 1644019-2025-04292
• Device Sequence Number: 18628183
• Product Code: LRO
• UDI-Device Identifier: 00380657524365
• UDI-Public: (01)00380657524365(17)261031(11)241111(10)174P65
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/17/2025

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 Catalogue Number: 8065752436
• Device Lot Number: 174P65
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 11/04/2025; 11/06/2025; 11/21/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/04/2025; 12/02/2025; 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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 Age: 48 YR
• Patient Sex: Female