MAUDE Adverse Event Report: NEW WORLD MEDICAL, INC AHMED GLAUCOMA VALVE; GLAUCOMA DRAINAGE DEVICE

Model Number	FP7
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Decreased (4468)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The ifu for the reported product model was reviewed and confirmed to include hypotony as a known complication.The device history record for the reported lot was reviewed and no issues were observed.Product was manufactured, tested, and released per validated procedures.As the device is not available for return, no device malfunction could be confirmed.
Event or Problem Description
Potential device malfunction; vision worsening, chamber flattening.

• Brand Name: AHMED GLAUCOMA VALVE
• Common Device Name: GLAUCOMA DRAINAGE DEVICE
• Manufacturer (Section D): NEW WORLD MEDICAL, INC; 10763 edison court; rancho cucamonga CA 91730
• Manufacturer (Section G): NEW WORLD MEDICAL, INC; 10763 edison court; rancho cucamonga CA 91730
• Manufacturer Contact: cristina avalos ; 10763 edison court; rancho cucamonga, CA 91730 ; 9094664304
• MDR Report Key: 23089346
• Report Number: 1000125279-2025-00029
• Device Sequence Number: 15914562
• Product Code: KYF
• UDI-Device Identifier: 00892064002119
• UDI-Public: (01)00892064002119(11)250501(17)270501(10)D1925
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K230975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FP7
• Device Catalogue Number: FP7
• Device Lot Number: D1925
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male