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

Catalog Number	8065830027
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/22/2025
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 vitrectomy probe had poor aspiration during the cataract and vitrectomy combination surgery.The surgery was completed after replacing the product with another one.There was no information about patient impact.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.The two returned product were visually inspected.Visual inspection confirmed that the aspiration line of the probe manifold was bent at the tubing insertion to the probe engine on one of the two samples.The defect prevented fluid from flowing from the probe to the cassette.The investigation conducted a non-conformance review of the reported lot number.No deviations that could have contributed to this event were identified and all corresponding production release specifications defined in the device master record were met.The most likely root cause for the customer¿s event is a manufacturing defect.The vitrectomy probe has a rear shell meant to improve the ergonomics of the handpiece, however, if the rear shell is improperly installed, it will result in the customers reported event.Action will not be taken based on this occurrence.An analysis of similar complaints confirmed no unfavorable trend for this event.Routine training is performed to ensure non-conforming product is rejected and placed in a reject bin during production.Quality assurance will continue to monitor and will take action for future occurrences as is deemed necessary.Consumables manufacturing has been made aware of the issue through the monthly complaint review meeting.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.No adverse trends have been observed associated with the reported product and event.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: 23677865
• Report Number: 1644019-2025-05177
• Device Sequence Number: 10260186
• Product Code: HQE
• UDI-Device Identifier: 00380658300272
• UDI-Public: (01)00380658300272(17)270531(11)250602(10)17F7D8
• 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): 03/17/2026

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: 17F7D8
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2025
• 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: CONSTELLATION VISION SYSTEM.
• Patient Sex: Unknown