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)
Date of Event	10/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On first surgery on (b)(6), when priming, the doctor felt it was not smooth but implanted anyway.Followed the patient for a few days, the iop did not get lower, and exchanged the valve with new one in emergency surgery on (b)(6).[patient information: (b)(6) years old, male, asian, asthma, high blood pressure, irregular pulse, used medicines: levofloxacin, betamethasone, bromfenac, glaualpha (diamox), (quenmet)].
Additional Manufacturer Narrative
The device history record for the reported lot was reviewed and no issues were observed.The product was manufactured, tested, and released per validated procedures.The explanted valve underwent visual inspection and functional testing.No issues were found with the device during visual inspection.A steady state pressure test was also conducted on the unit to mimic the physiological flow conditions of the human eye, where the resulting pressure in the system measured and yielded passing results.The returned valve met the acceptance criteria and performed as expected.The issue of high iop as reported by customer could not be replicated or confirmed.

• 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: 23662960
• Report Number: 1000125279-2025-00046
• Device Sequence Number: 10406153
• Product Code: KYF
• UDI-Device Identifier: 00892064002119
• UDI-Public: (01)00892064002119(11)250415(17)270415(10)D0225
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/26/2025

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: D0225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• 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: Male
• Patient Race: Asian