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

Catalog Number	8065830027
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
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 cutter could not cut during the cataract and vitrectomy combination surgery.The surgery was completed on same day.How surgery completed was unknown.The product was contacted with patient but there was no patient impact.
Additional Manufacturer Narrative
Additional information provided in d.9., h.6.And h.11.No technical inquiries were received from the customer.The opened probe returned for evaluation was not within the reported pak lot number reported based on radio frequency identification (rfid) tag identification; therefore, no sample evaluation was performed.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 nonconformance review of the reported lot.A nonconformance was found.This non-conformance could have potentially contributed to the reported event.Two non-conformance records were initiated to trend the defect of excessive adhesive at the diaphragm/extension and one non-conformance record was completed to trend the defect of excessive adhesive at the cutter/coupling.Based on the evaluation of the information and materials received (the reported product and lot was not 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, the returned sample lot number was not within the reported pak lot number based on rfid tag identification; therefore, specific actions with regard to this complaint cannot be taken.A non-conformance record has been completed in relation to the related non-conformances identified within the non-conformance review.A nonconformance investigation has been completed to investigate the trend identified for probes with would not cut or actuate issues.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.Complaint data for all products is reviewed monthly to monitor for adverse trends.During the last review, 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: 23797849
• Report Number: 1644019-2025-05475
• Device Sequence Number: 14839317
• Product Code: HQE
• UDI-Device Identifier: 00380658300272
• UDI-Public: (01)00380658300272(17)270131(11)250208(10)1789MH
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170520
• 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): 04/16/2026

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: 8065830027
• Device Lot Number: 1789MH
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 12/13/2025
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2025
• 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