MAUDE Adverse Event Report: ALCON LABORATORIES CELLUGEL, 1.0 ML

Model Number 00380651838109

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2016

Event Type  malfunction  

Event Description

During vitrectomy and scleral buckle, the alcon cellugel cannula adapter would not stay secure to the syringe.This was replaced with another "like" device that functioned without issue.

• Brand Name: CELLUGEL, 1.0 ML
• Type of Device: CELLUGEL, 1.0 ML
• Manufacturer (Section D): ALCON LABORATORIES; fort worth TX 76134
• MDR Report Key: 5528963
• MDR Text Key: 41339098
• Report Number: MW5061266
• Device Sequence Number: 1
• Product Code: LZP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: 00380651838109
• Device Catalogue Number: 00380651838109
• Device Lot Number: 15K10G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR