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	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Device return is pending confirmation of availability.If the device is returned to new world medical, an addendum will be filed upon completion of the evaluation.
Event or Problem Description
Summary of the event: based on the investigation conducted, the analysis of the description, and during the use of the medical device, it was detected that the valve tube was perforated with an irregular tear.The ophthalmologist specializing in glaucomatology decided to replace the valve plate, which she did without affecting the patient.Analysis of the probable cause: the probable cause of the incident is the rupture of the silicone material of the valve tube, suggesting a problem with the medical device itself.This could be due to a defect in the design or manufacture of the device.Classification of the event: because the problem appears to be related to the design or manufacture of the medical device, this event is classified as an adverse incident.However, as there was no impact on the patient or serious compromise to their health, the incident is determined to be non-serious.Determination of the severity of the event: the event is classified as non-serious because, although there was a problem with the medical device, there was no harm or injury to the patient, and the medical intervention was effective with no negative short- or long-term consequences for the patient.Conclusion: the case or event involving the fp7 glaucoma valve, marketed under the name fp7 ahmed glaucoma valve shunt, is classified as a non-serious adverse event because the problem appears to be related to the medical device itself, but there was no impact on the patient or serious compromise to his health.

• 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: 23475938
• Report Number: 1000125279-2025-00043
• Device Sequence Number: 21456151
• Product Code: KYF
• UDI-Device Identifier: 00892064002119
• UDI-Public: (01)00892064002119(11)250319(17)270319(10)C1025
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/04/2025

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
• Operator of Device: Health Professional
• Device Model Number: FP7
• Device Catalogue Number: FP7
• Device Lot Number: C1025
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2025
• 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