MAUDE Adverse Event Report: Alcon Grieshaber AG Backflush Handle DSP; Instrument, Vitreous Aspiration and Cutting, AC-Powered, Accessory

Catalog Number	337.84
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/14/2026
Type of Reportable Event	Malfunction

• Brand Name: Backflush Handle DSP
• Common Device Name: Instrument, Vitreous Aspiration and Cutting, AC-Powered, Accessory
• Manufacturer (Section D): Alcon Grieshaber AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer (Section G): Alcon Grieshaber AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; +1(800)757-9780
• MDR Report Key: 50745345
• Report Number: 3003398873-2026-00189
• Device Sequence Number: 8450323
• Product Code: HQE
• UDI-Device Identifier: 07612717071193
• UDI-Public: (01)07612717071193(17)290131(11)260216(10)17XW79
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K884043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: 337.84
• Device Lot Number: 17XW79
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/12/2026
• Date Device Manufactured: 02/16/2026
• 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