MAUDE Adverse Event Report: AMO Manufacturing Netherlands Baerveldt Shunt; Implant, Eye Valve

Model Number	BG102-350
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: Baerveldt Shunt
• Common Device Name: Implant, Eye Valve
• Manufacturer (Section D): AMO Manufacturing Netherlands; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; +1(714)247-8552
• MDR Report Key: 50063563
• Report Number: 3012236936-2026-000197
• Device Sequence Number: 10731235
• Product Code: KYF
• UDI-Device Identifier: 05050474513006
• UDI-Public: (01)05050474513006(17)270408
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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 Model Number: BG102-350
• Device Catalogue Number: 23030818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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