MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON HYPERVIT VITRECTOMY PROBE; VITRECTOMY, INSTRUMENT CUTTER

Catalog Number	8065000250
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
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 aspiration could not be achieved due to backflow that occurred during the surgery the procedural type was unknown.The surgery was completed on the same day after replacing the product with another one.There was no patient impact.
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 clear foreign material in the port.The sample was then functionally tested for actuation and aspiration.The sample was found to be nonconforming for both tests.The probe was disassembled and the components inspected.Nominal wear observed on inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Gouge marks observed at the bend area.The sample was tested with a syringe and resistance was felt.A wire was inserted through the aspiration path.The sample was retested with a syringe, and no resistance was felt.The sample was retested for actuation and aspiration with the probe driver and was able to actuate and aspirate.The initial actuation and aspiration test failed due to an interference in the aspiration path and once the interference was removed the probe was able to actuate and aspirate.The probe engine was disassembled, and the components were inspected.Bottom o-ring, spacer, and diaphragm are all intact.Top o-ring is damaged.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 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 an aspiration failure and indicated an actuation failure.The root cause of the actuation and aspiration failure is an interference in the aspiration path once the interference was removed the probe was able to actuate and aspirate.However, the exact root cause of the interference could not be determined from the evaluation performed.A potential manufacturing-related contributing factor was identified.Specifically, damage to the o ring was observed during the evaluation.This condition may have contributed to the device performance issue and therefore cannot be ruled out as potential contributors to the event as reported.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time as the probe sample was able to actuate and aspirate once the observed interference was removed.A non-conformance was completed for the damage observed on the o-ring.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: HYPERVIT VITRECTOMY PROBE
• Common Device Name: VITRECTOMY, INSTRUMENT CUTTER
• 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: 24528334
• Report Number: 1644019-2026-01323
• Device Sequence Number: 15579401
• Product Code: HQE
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K233876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2026

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: 8065000250
• Device Lot Number: 17FD7M
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 06/13/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 07/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2025
• 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