MAUDE Adverse Event Report: LIFECORE BIOMEDICAL AMVISC PLUS ; AID SURGICAL VISCOELASTIC

Model Number 60081L

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/13/2015

Event Type  malfunction  

Event Description

It was reported that during cataract surgery, the physician was expressing viscoelastic into the pt's eye when the cannula detached from the luer lock and shot out in the pt's eye.The surgeon used another viscoelastic to complete the procedure.

Manufacturer Narrative

Investigation of this event is in progress.A supplemental report will be submitted, upon completion of the investigation.

Manufacturer Narrative

The device was not returned to b+l for evaluation therefore, product evaluation could not be conducted.The device history records were reviewed and there were no discrepancies or unusual findings that relate to the reported issue.Based on the information available, the exact cause of the reported event could not be conclusively determined.

• Brand Name: AMVISC PLUS
• Type of Device: AID SURGICAL VISCOELASTIC
• Manufacturer (Section D): LIFECORE BIOMEDICAL; chaska MN
• Manufacturer (Section G): LIFECORE BIOMEDICAL, LLC ; 3515 lyman blvd ; chaska MN 55318
• Manufacturer Contact: sharon spencer ; 1400 north goodman st.; rochester, NY 14609-3547 ; 9493985698
• MDR Report Key: 4840743
• MDR Text Key: 5873358
• Report Number: 1313525-2015-01574
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: 60081L
• Device Lot Number: 025712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1