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 Codes	Intraocular Pressure Increased (1937); Intraocular Pressure Decreased (4468)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record (dhr) for the reported lot was reviewed and no issues were observed.Product was manufactured, tested, and released per validated procedures.The device was reported to be explanted and pending return to new world medical.Upon device return and evaluation, an addendum will be filed.
Event or Problem Description
Per the surgeon the valve malfunctioned and remained open.The surgeon replied, "it failed to open high pressures".
Additional Manufacturer Narrative
Device received with a note stating: valve malfunction - remained open until iop was 0.Therefore the ifu for the reported product model was reviewed and confirmed to include hypotony as a known complication.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 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 ; 9098705446
• MDR Report Key: 25194772
• Report Number: 1000125279-2026-00022
• Device Sequence Number: 10403055
• Product Code: KYF
• UDI-Device Identifier: 00892064002119
• UDI-Public: (01)00892064002119(11)251007(17)271007(10)K1425
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K230975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• 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: K1425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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