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	06/30/2025
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 has not yet been returned, no device malfunction could be confirmed.
Event or Problem Description
Patient underwent ahmed implant surgery on (b)(6) 2025 by prof (b)(6).During the surgery, prof (b)(6) primed the tube, and did not note of any abnormalities.Surgery was uneventful.However, patient had persistent hypotony postoperatively.Subsequently, a repeat surgery (tube revision) was done on (b)(6) 2025 by dr (b)(6) and below were the surgeon findings: -valve failure -peritubular leak & over filtration.The tube was subsequently ligated with 6/0 vicryl suture.
Additional Manufacturer Narrative
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 low 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: 22549457
• Report Number: 1000125279-2025-00025
• Device Sequence Number: 9229347
• Product Code: KYF
• UDI-Device Identifier: 00892064002119
• UDI-Public: (01)00892064002119(11)250122(17)270122(10)A0925
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: A0925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 12/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• 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