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

Catalog Number	8065750914
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that the tube was not delivering water during vitrectomy surgery.The surgery was completed on the same day after replacing the product with another one.There was no impact to the patient.
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 returned infusion manifold was visually inspected and found to be in good condition with no obvious defects.A lab control pack was used to test the manifold, and the connectors attached to the cassette without any interference.Functional testing showed that the system could prime normally and complete calibration without any air leaks, occlusions, or error messages.Cleaning could also be performed without issue.All functional checks met the applicable performance requirements.Additional testing confirmed that infusion pressure, and flow rate were all within specification.During operation, fluid flowed continuously from the cassette without introducing air into the infusion line.When the system was switched to fluid/air exchange mode, only air was delivered as intended.Overall, the returned product performed as expected and no malfunction could be reproduced.The investigation conducted a non-conformance review of the reported lot number.No deviations were identified that would have contributed to the reported event 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 as the product functioned per specifications.Additionally, no manufacturing-related deficiencies were found that potentially could have contributed to the complaint.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, therefore no action will be taken for this occurrence.Complaint data for all 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, INFUSION 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: 23919497
• Report Number: 1644019-2025-05852
• Device Sequence Number: 9295688
• Product Code: HQC
• UDI-Device Identifier: 00380657509140
• UDI-Public: (01)00380657509140(17)260731(11)240801(10)17097U
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101285
• 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): 05/06/2026

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 8065750914
• Device Lot Number: 17097U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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
• Patient Sex: Unknown