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

Catalog Number	8065830077
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that the aspirator was not cutting during vitrectomy surgery.The procedure was completed.It was unknown how the procedure was completed.There was no reported information about patient impact.Additional information has been requested.None received till date.
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.The results of the investigation found the probe aspiration tubing kinked and folded underneath the probe rear shell which will prevent probe aspiration and result in the customer's experience.The vitrectomy probe¿s rear shell is meant to improve the ergonomics of the handpiece, however, if the rear shell is improperly installed, it will result in the folded tubing observed.The investigation conducted a non-conformance review of the reported lot number.No deviation was identified that would have contributed to this event and all corresponding production release specifications defined in the device master record were met.The most likely root cause was related to an operator improperly connecting the probe rear shell to the probe engine after the probe was leak and flow tested.The rear shell should be manually connected by the operator prior to the probe test.After final assembly of each probe, a leak and flow test is performed at the tester station to detect and screen out nonconforming probes such as a kink on the aspiration line.Based on the results of the investigation, no additional manufacturing or corrective actions are required at this time.Current complaint tracking shows no adverse trends associated with this product or the reported failure mode.Each probe undergoes a leak and flow test at the tester station after final assembly to identify and prevent release of nonconforming units, including those with aspiration line kinks.This process is established and continues to be verified through routine quality monitoring.Complaint data for all company products is reviewed monthly to monitor for adverse trends.During the last review, no 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: 23922625
• Report Number: 1644019-2025-05870
• Device Sequence Number: 9041282
• Product Code: LRO
• UDI-Device Identifier: 00380658300777
• UDI-Public: (01)00380658300777(17)270331(11)250411(10)17C7E5
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: 8065830077
• Device Lot Number: 17C7E5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2025
• 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: CONSTELLATION VISION SYSTEM.; CUSTOM-PAK SURGICAL PROCEDURE PACK.
• Patient Sex: Unknown