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

Model Number	CP250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Decreased (4468)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient recovered spontaneously w1 postop.No device problem detected.Serial and lot number was not provided although requested.If additional information is provided an addendum will be filed.
Event or Problem Description
Patient's iop dropped from 15 mmhg (baseline) to 2 mmhg d1 postop.Iop increased to 10 mmhg at w1 postop.
Additional Manufacturer Narrative
Received the lot number information and completed review of dhr.Product in the reported was manufactured, tested, and released in compliance with new world medical procedures.The reported issue could not be confirmed with the additional information.

• 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 ; 9098705446
• MDR Report Key: 17065177
• Report Number: 1000125279-2023-00021
• Device Sequence Number: 6739063
• Product Code: KYF
• UDI-Device Identifier: 00892064002348
• UDI-Public: (01)00892064002348(11)211024(17)231024(10)L0121
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2023

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 Expiration Date: 10/24/2023
• Device Model Number: CP250
• Device Catalogue Number: CP250
• Device Lot Number: L0121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2023
• Supplement Date Received by Manufacturer: 05/06/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2021
• 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: Other
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White