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

Catalog Number	8065751058
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
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 nurse reported that the air and fluid exchange was failed during vitrectomy surgery.The surgery was completed after replacing the product with new one.There was no patient impact.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6., and h.11.Upon visual inspection of the returned cassette an identification (id) tab on the pinch plate was broken off.When the cassette was inserted onto a calibrated console the cassette was recognized as a posterior cassette with manual stopcock and passed priming and intraocular pressure (iop) calibration successfully.The ¿manual stopcock¿ output displayed by the console for the posterior cassette is incorrect for the cassette type and will result in fluid/air exchange (fax) detection issues the customer experienced.During fluid and air exchange (fax) mode, there was no exchange from liquid to air, liquid continued to flow to the infusion cannula.The customer's experience was replicated during laboratory testing.The investigation conducted a non-conformance review of the reported lot number.No deviation were 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 of the customer's complaint is related to an error in the molding process of the id tabs to the pinch plate during manufacturing.The molding defect observed can result in unwanted stress on the id tab during cassette ejection and can break off which can lead to the customer's experience.Other potential contributing factors could be physical impact during storage post-receipt of the product and material movement of the pinch plate and/or cassette by the operator during production.After an investigation of this complaint, it has been determined that no further actions will be pursued at this time.No adverse trends have been observed associated with the reported product and event.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.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.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: 23308290
• Report Number: 1644019-2025-04050
• Device Sequence Number: 14903294
• Product Code: LRO
• UDI-Device Identifier: 00380657510580
• UDI-Public: (01)00380657510580(17)270430(11)250531(10)17EEEK
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: 8065751058
• Device Lot Number: 17EEEK
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2025
• 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