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

Catalog Number	8065751468
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Retinal Tear (2050)
Date of Event	04/30/2025
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 during vitrectomy surgery while cutting the peripheral vitreous, the patient experienced severe disturbance and retinal traction.Realizing the issue, the surgery was immediately halted and the kit was replaced.Upon inspecting the vitrectomy cutter, it was found that the tip of the probe was broken.The current patient condition was unknown.
Additional Manufacturer Narrative
Additional information provided in b.5.And h.11.Based on new information received, the tip of probe was missing upon opening the pack from the beginning.Not during the surgery.No possibility of remaining in patient's eye.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Based on new information received, the tip of probe was missing upon opening the pack from the beginning.Not during the surgery.No possibility of remaining in patient's eye.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.One opened probe was received, with a tip protector, in a tray, for the report.The sample was visually inspected and found to be nonconforming with the probe needle broken at the port.The probe was disassembled and the components inspected.Excessive wear observed on inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.A review of the device history record traceable to the lot number obtained from the device¿s radio frequency identification tag, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The photo attached was reviewed by the manufacturing site.Photo show a broken probe tip.Reported issue 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 confirms the probe had a broken tip.The root cause for the broken tip is due to the excessive surgical use of the probe.The wear observed on inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos is consistent with excessive use classification.Excess usage of the probe will wear and damage the inner cutter such that the cutter function becomes poor, bent, or does not function at all.Per the direction for use, the vitrectomy probe is verified for twenty minutes of use at maximum cut speed.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time as observed broken tip was due to excessive use of the probe by the user.All probes are hundred percent 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: 22068463
• Report Number: 1644019-2025-01550
• Device Sequence Number: 18320887
• Product Code: LRO
• UDI-Device Identifier: 00380657514687
• UDI-Public: (01)00380657514687(17)260731(11)240802(10)1707M1
• 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): 09/23/2025

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: 07/31/2026
• Device Catalogue Number: 8065751468
• Device Lot Number: 1707M1
• 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: 05/01/2025
• Supplement Date Received by Manufacturer: 05/27/2025; 08/28/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/19/2025; 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2024
• 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 Sex: Unknown