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

Catalog Number	8065830077
Medical Device Problem Codes	Fitting Problem (2183); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that the vitrectomy cutter had a notch (deformed) and did not fit tip during the vitrectomy surgery.The surgery was completed on same day by replacing the custom pak.The product was contacted with patient, but 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 d.9., h.3., h.6.And h.11.No technical inquiries were received from the customer.One opened probe was received, with a tip protector, in a plastic bag.The sample was visually inspected and found to be nonconforming with white/clear foreign material on the needle and inside the port.Orange/brown foreign material on the port face and inside the port.No bent or damage/deformed condition was observed on the needle.The probe needle was fit tested for function through a ring gauge and was found non-conforming.The probe did not travel in and out of the ring gauge under its own weight.The foreign material was wiped off of the probe needle and then the probe needle was fit tested again with the ring gauge and was able to travel in and out of the ring gauge under its own weight.A review of the device history record traceable to the lot number obtained from the device¿s radio frequency identification (rfid) tag, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The photo was reviewed by the manufacturing site.Photo show a label with reported cpak lot number.Reported issue cannot be confirmed from photo.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.Additionally, no manufacturing-related deficiencies were found that potentially could have contributed to the complaint.The complaint evaluation does not confirm reported bent needle condition.The complaint evaluation confirms the probe had a fit issue.The fit issue was due to the foreign material on the needle.The exact source of the foreign material cannot be determined from this evaluation.However, the most likely contributing factor is surgical residue from use and does not point to a manufacturing issue due to the foreign material easily wiping off with alcohol.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time as probe bent condition was not confirmed and product met specification once the foreign material was removed.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformances found are removed from the lot and scrapped.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.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 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: 24113705
• Report Number: 1644019-2026-00436
• Device Sequence Number: 14925368
• Product Code: LRO
• UDI-Device Identifier: 00380658300777
• UDI-Public: (01)00380658300777(17)270630(11)250710(10)17HWJ9
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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: 8065830077
• Device Lot Number: 17HWJ9
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CUSTOM-PAK SURGICAL PROCEDURE PACK.
• Patient Age: 62 YR
• Patient Sex: Male