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

Catalog Number	8065750914
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Choroidal Hemorrhage (4810)
Date of Event	01/06/2025
Type of Reportable Event	Serious Injury
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 there was no gas flow in the gas infusion pipeline with an automatic infusion valve during retinal surgery.The patient experienced choroidal hemorrhage.The patient was recovering from the symptoms.The involved eye was unknown.The procedure type was unknown.The surgery was completed on the same day after replacing the product with another one.
Additional Manufacturer Narrative
Additional information provided in a.2., a.3a., h.2., and h.11.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The used console infusion manifold was visually inspected, and no obvious defects were found.The combined console pak from lab stock was used for testing.The infusion manifold connectors were connected to the lab stock cassette without any interference and could fully engage.We did note the infusion cannula assembly, or the cassette associated with this event was not returned for a full evaluation.The sample could prime and pass intraocular pressure (iop) calibration successfully.No anomalies were observed during priming.The infusion pressure was measured at multiple set points throughout the console range and met specifications.Toggling the infusion and the fluid/air exchange (f/ax) modes, fluid and air flowed from the cassette to the infusion line continuously without any bubble in various settings in all sub modes.With the infusion control on, fluid flowed from the cassette continuously without generating air to the infusion line.When the fluid/air exchange (f/ax) control was on, only air was introduced from the cassette to the infusion line.There was no occlusion detected within the infusion tubing set during evaluation.We were unable to replicate the customer's experience during laboratory evaluation.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 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 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, 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: 21190520
• Report Number: 1644019-2025-00252
• Device Sequence Number: 11642186
• Product Code: HQC
• UDI-Device Identifier: 00380657509140
• UDI-Public: (01)00380657509140(17)260228(11)240320(10)16M4J9
• 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,Followup
• Report Date (Section B): 05/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 8065750914
• Device Lot Number: 16M4J9
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: 01/24/2025; 05/09/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 02/13/2025; 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Sex: Male