MAUDE Adverse Event Report: Alcon Research, LLC - Houston HyperVit Vitrectomy Probe; Vitrectomy, Instrument Cutter

Catalog Number	8065830026
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported via health authority that vitrectomy probe was not be recognized and could not be used during surgery.The procedure type was unknown.The surgery was completed on same day, but it was unknown how the surgery was completed.There was no information about the patient impact.
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).

• 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 ; +1(800)757-9780
• MDR Report Key: 50211538
• Report Number: 1644019-2026-04265
• Device Sequence Number: 6099489
• Product Code: HQE
• UDI-Device Identifier: 00380658300265
• UDI-Public: (01)00380658300265(17)271231(11)260107(10)17VH99
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K170520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: 8065830026
• Device Lot Number: 17VH99
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 08/11/2026
• Date Device Manufactured: 01/07/2026
• 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