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 Increased (1937)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record (dhr) for the reported lot was also reviewed, and no issues were found; the product was manufactured, tested, and released according to validated procedures.The explanted valve underwent visual inspection and functional testing, with no issues identified.Additionally, a steady state pressure test was conducted to simulate physiological flow conditions, and the valve passed the test with results within the expected range.As the reported issue of high iop could not be replicated or confirmed, the returned valve met the acceptance criteria and performed as expected during testing.
Event or Problem Description
Product malfunction after implanted to patient.Had to be explanted a week later and replace with new one.

• 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: 22179168
• Report Number: 1000125279-2025-00019
• Device Sequence Number: 8562271
• Product Code: KYF
• UDI-Device Identifier: 00892064002119
• UDI-Public: (01)00892064002119(11)250304(17)270304(10)B1825
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K230975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/10/2025

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
• Device Model Number: FP7
• Device Catalogue Number: FP7
• Device Lot Number: B1825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2025
• 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 Sex: Unknown