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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
Fp7 stopped functioning.
Additional Manufacturer Narrative
The device history record (dhr) for the reported lot was reviewed and no issues were identified.The product was manufactured, tested, and released in accordance with validated procedures and established acceptance criteria.Visual inspection of the returned device revealed damage incurred upon explantation.Due to this damage, the device was unable to undergo functional testing, including the steady state pressure test that mimics physiological ocular flow conditions.The valve was successfully primed without issue.Based on the evaluation performed, the reported issue could not be replicated or confirmed, and a manufacturing-related cause could not be established.

• 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 ; +1(909)870-5446
• MDR Report Key: 50899347
• Report Number: 1000125279-2026-00036
• Device Sequence Number: 18817849
• Product Code: KYF
• UDI-Device Identifier: 00892064002119
• UDI-Public: (01)00892064002119(11)260322(17)280322(10)C0626
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K230975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 09/23/2026

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 Expiration Date: 03/22/2026
• Device Model Number: FP7
• Device Catalogue Number: FP7
• Device Lot Number: C0626
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2026
• 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: 76 YR
• Patient Sex: Male