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

Catalog Number	8065830026
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction

• 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: 50647235
• Report Number: 1644019-2026-04628
• Device Sequence Number: 10485133
• Product Code: HQE
• UDI-Device Identifier: 00380658300265
• UDI-Public: (01)00380658300265(17)280131(11)260218(10)17X178
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2026

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: 17X178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 09/07/2026
• Date Device Manufactured: 02/18/2026
• 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