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	05/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The ifu for the reported product model was reviewed and confirmed to include hypotony and choroidal detachment as a known complication.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.As the device is not available for return, no device malfunction could be confirmed.
Event or Problem Description
Patient undergone an ahmed tube implant by dr (b)(6)/ (b)(6) on (b)(6) 2026.Dr (b)(6) primed the tube and did not note of any abnormalities.Surgery was uneventful.However, patient had persistent hypotony postoperatively.(b)(6) 2026, pod 5, noted over-filtering tube vs peritubular leak (large bleb) iop 2- healon gv injected.The plate was covered by conj and tutoplast, with sutures intact and watertight with no leaks.On (b)(6) 2026, patient returned to ot for tube ligation/stenting kiv conj autograft intraoperative findings on (b)(6) 2026 noted: over-filtration, valve failure, no peritube leak.Surgeons stented the tube plate junction with 4/0 prolene and closed the wound in the meantime, the team is still monitoring the patient.

• 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 ; 9098705446
• MDR Report Key: 25415041
• Report Number: 1000125279-2026-00027
• Device Sequence Number: 15818844
• Product Code: KYF
• UDI-Device Identifier: 00892064002119
• UDI-Public: (01)00892064002119(11)250908(17)270908(10)J1225
• 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: 2026
• 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): 06/04/2026

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 Model Number: FP7
• Device Catalogue Number: FP7
• Device Lot Number: J1225
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2025
• 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