MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON UNITY TOTAL PLUS Combined Procedure Pack; GENERAL SURGERY TRAY (KIT)

Catalog Number	8065000382
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that cutter kept malfunctioning while cutting during the vitrectomy surgery.The cut rate was 7500 and no system message was displayed.The surgery was completed after replacing the product with another one.The patient was not affected.
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.A sample was not received at the investigation site for evaluation for the report; therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.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 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.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.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.4., d.9., h.3., h.6.And h.11.No technical inquiries were received from the customer.One opened probe without tip protector in a pouch was received for the report.The sample was visually inspected and found to be nonconforming with needle severely bent at the stiffener.The sample could not be functionally tested for actuation or cut due to severely bent needle.The probe was disassembled and the components inspected.Excessive wear was observed on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Gouge marks were observed at the bend area and cutting edge.Inner cutter was bent.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 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 complaint evaluation confirms the probe had a cut failure.The probe was disassembled and the components inspected.The wear observed on the 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 cutter function becomes poor, bent, or does not function at all.Per the direction for use (dfu), the vitrectomy probe is verified for 20 minutes of use at maximum cut speed.No further investigative or manufacturing actions are warranted at this time due to the observed cut failure being attributed to excessive use of the probe by the user.Per the dfu, the vitrectomy probe is verified for 20 minutes of use at maximum cut speed.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 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).

• Brand Name: UNITY TOTAL PLUS Combined 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: 24629592
• Report Number: 1644019-2026-01599
• Device Sequence Number: 9015307
• Product Code: LRO
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 08/31/2026

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: 8065000382
• Device Lot Number: 17DPNK
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/08/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 05/19/2026; 08/06/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 06/09/2026; 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2025
• 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