MAUDE Adverse Event Report: ALCON RESEARCH, LTD. CUSTOM-PAK; GENERAL SURGERY TRAY

Catalog Number 2223-25

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Information (3190)

Event Date 08/08/2018

Event Type  malfunction  

Event Description

During cataract surgery, a fiber was noted in the anterior chamber and was removed using manipulation with fine forceps through the main wound.The wounds were again hydrated until all wounds were watertight.

• Brand Name: CUSTOM-PAK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): ALCON RESEARCH, LTD.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 7909668
• MDR Text Key: 121732043
• Report Number: 7909668
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/18/2018,09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2223-25
• Device Lot Number: 216452211
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/18/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20805 DA
• Patient Weight: 59