MAUDE Adverse Event Report: NEW WORLD MEDICAL, INC. AHMED GLAUCOMA VALVE; IMPLANT, EYE VALVE

Catalog Number FP7

Device Problem Defective Component (2292)

Patient Problem Glaucoma (1875)

Event Type  Injury  

Event Description

Ahmed glaucoma valve implanted was discovered to be defective.Fda safety report id # (b)(4).

• Brand Name: AHMED GLAUCOMA VALVE
• Type of Device: IMPLANT, EYE VALVE
• Manufacturer (Section D): NEW WORLD MEDICAL, INC.
• MDR Report Key: 9671249
• MDR Text Key: 177986549
• Report Number: MW5092749
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/03/2021
• Device Catalogue Number: FP7
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1