MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION VISION SYSTEM, ACCESSORY, IRRIGATION/ASPIRATION TUBING SET; UNIT, PHACOFRAGMENTATION

Catalog Number	8065750918
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2025
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 non-health care professional reported that tubing obstruction impediment before intraocular lens implantation surgery.Procedure completion details were unknown.There was no patient impact reported.
Additional Manufacturer Narrative
Additional information provided in d.9., h.2., h.3., h.6.And h.11.The used irrigation/aspiration (i/a) manifold was visually inspected.The blue luer on the i/a manifold was deformed.The deformed blue luer on the i/a manifold appeared to be damaged during molding.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.After an analysis and based on the condition of the sample, the root cause is potentially related to an error during the suppliers molding process of the connector.The supplier has been notified of this complaint and will take appropriate actions as necessary.All lots are verified that all required inspections have been performed and all acceptance criteria are met prior to release.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 VISION SYSTEM, ACCESSORY, IRRIGATION/ASPIRATION TUBING SET
• Common Device Name: UNIT, PHACOFRAGMENTATION
• 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: 22000191
• Report Number: 1644019-2025-01421
• Device Sequence Number: 18489479
• Product Code: HQC
• UDI-Device Identifier: 00380657509188
• UDI-Public: (01)00380657509188(17)260930(11)241002(10)172Y28
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K101285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: 09/30/2026
• Device Catalogue Number: 8065750918
• Device Lot Number: 172Y28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• 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
• Patient Sex: Unknown