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

Catalog Number	8065751767
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
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 physician reported that the cassette leakage occurred before vitrectomy surgery.The procedure was completed by replacing the product with new one.There was no patient impact.
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., e.1., h.3., h.6., and h.11.A wet pak was returned and visually inspected.The identification tab of the pinch plate was broken off.When the cassette was inserted into the console, the cassette was ejected by the console.A submerge leak test was performed on the cassettes.No leakage was observed on the returned cassette.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.The root cause of the customer's complaint is related to an error in the molding process of the identification (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.After an investigation of this complaint, it has 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: 23566887
• Report Number: 1644019-2025-04750
• Device Sequence Number: 13233071
• Product Code: LRO
• UDI-Device Identifier: 00380657517671
• UDI-Public: (01)00380657517671(17)251231(11)240106(10)16ELNN
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2026

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: 12/31/2025
• Device Catalogue Number: 8065751767
• Device Lot Number: 16ELNN
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 11/21/2025; 02/26/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/19/2025; 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2024
• 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