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

Catalog Number	8065750914
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that the device passed inspection and it was discovered that the tube was not delivering water during vitrectomy surgery.The product was promptly replaced with a new one, and the surgery was completed successfully.There was no patient impact.
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 h.6.And h.11.Product evaluation was not able to be performed since the reported product was not received at the investigation site for evaluation.Product is expected but has not been returned to date.Receipt of complaint product or additional information pertinent to this complaint will result in re-evaluation of the complaint investigation.The investigation conducted a non-conformance review of the reported lot number.No deviations that could have contributed to this event were identified and all corresponding production release specifications defined in the device master record were met.Based on the evaluation of the information, the investigation was unable to conclusively 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.No further investigative or manufacturing actions are warranted at this time due to the product not being returned to the manufacturing site for testing.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, 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).
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.Evaluation of the returned product confirms the top and base of the auto infusion valve (aiv) separated indicating a weak weld between the two components which can result in the customer's experience.The auto infusion valve (aiv) is located on the infusion manifold assembly (tubing set).An aiv process review was performed to include testing, training, and design.The investigation found the aiv tops and bases do not have energy directors.These energy directors primarily help focus and direct the ultrasonic energy to the weld location.Adding energy directors to either the aiv top or base can enable the formation of better and stronger welds.In addition, there were steps of training identified related to in-process testing that likely contributed to this event.The investigation conducted a non-conformance review of the reported lot number.No deviations that could have contributed to this event were identified, all corresponding production release specifications defined in the device master record were met.The root cause of this event was determined to be related to the manufacturing process.The following contributing factors were identified; inadequate in-process testing to detect weak aiv welds, inadequate training for aiv operators to conduct the ¿squeeze/pinch test¿ between the top and base, and design factors.An internal investigation was completed, action was taken to address each of the contributing factors identified.Actions include procedural enhancements, validation of new molds for the top and base to ensure continued control of critical dimensions and an enhancement to the aiv design to promote a better weld.Complaints are reviewed and monitored for adverse trends on a monthly basis.An adverse trend has been identified related to broken fluid air exchange components.This event is associated with this trend.A non-conformance investigation was conducted, corrective and preventative action implementation is on-going.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 is 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: 24066264
• Report Number: 1644019-2026-00361
• Device Sequence Number: 10226572
• Product Code: HQC
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2026

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: 8065750914
• Device Lot Number: 179M9J
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 02/12/2026; 06/11/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/03/2026; 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2025
• 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
• Patient Sex: Unknown