MAUDE Adverse Event Report: ALCON RESEARCH, LTD. MONARCH III "D"; DELIVERY SYSTEM CARTRIDGE

Catalog Number 8065977763

Device Problem Metal Shedding Debris (1804)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/02/2017

Event Type  malfunction  

Event Description

Black debris was seen on the artificial lens when it was inserted into the eye.The surgeon was able to remove the debris.

• Brand Name: MONARCH III "D"
• Type of Device: DELIVERY SYSTEM CARTRIDGE
• Manufacturer (Section D): ALCON RESEARCH, LTD.; 714 columbia ave.; sinking spring PA 19608
• MDR Report Key: 6364226
• MDR Text Key: 68504249
• Report Number: 6364226
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2017,02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 8065977763
• Device Lot Number: 32500961
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ARTIFICIAL LENS, LUBRICANT, DELIVERY SYSTEM CARTRI
• Patient Age: 65 YR
• Patient Weight: 114