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)
Type of Reportable Event	Serious Injury
Event or Problem Description
After implanting an fp7 valve of lot d0625, the patient was admitted with atalamia.
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 has not yet been returned, no device malfunction could be 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: 22549459
• Report Number: 1000125279-2025-00023
• Device Sequence Number: 9229349
• Product Code: KYF
• UDI-Device Identifier: 00892064002119
• UDI-Public: (01)00892064002119(11)250422(17)270422(10)D0625
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K230975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2025

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
• Device Model Number: FP7
• Device Catalogue Number: FP7
• Device Lot Number: D0625
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2025
• 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