MAUDE Adverse Event Report: NEW WORLD MEDICAL, INC. AHMED CLEARPATH; GLAUCOMA DRAINAGE DEVICE

Model Number	CP250
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Eye Infections (4466)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record for the reported lot was reviewed and no issues were observed.Product was manufactured, tested, and released per validated procedures.The explanted device underwent visual inspection and no issues were found with the device during visual inspection.As indicated by customer when reported the issue, the device was not considered as the cause for the infection but had to be removed as a consequence of an infection that spread to the device.
Event or Problem Description
The patient had an eye infection, that did not start with the tube but spread to the tube resulting in the tube needing to be removed.

• Brand Name: AHMED CLEARPATH
• 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: 22367185
• Report Number: 1000125279-2025-00021
• Device Sequence Number: 7953260
• Product Code: KYF
• UDI-Device Identifier: 00892064002348
• UDI-Public: (01)00892064002348(11)220422(17)240422(10)D0622
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K182518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/30/2025

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 Expiration Date: 04/22/2024
• Device Model Number: CP250
• Device Catalogue Number: CP250
• Device Lot Number: D0622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown