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

Model Number 60082L

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/20/2015

Event Type  malfunction  

Event Description

It was reported that during cataract surgery the physician was expressing the viscoelastic into the pt's eye when the cannula came off.The surgeon retrieved it and no injury was reported.It is to be noted that reportedly, the new scrub tech did not realize that there was no luer lock prior to usage.

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 lot number of the delivery device was not provided; therefore, a device history record (dhr) review could not be performed.Based on the information available, the exact cause of the reported event could not be conclusively determined.

• Brand Name: AMVISC PLUS VISCOSURGICAL DEVICE
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): LIFECORE BIOMEDICAL; chaska MN
• Manufacturer (Section G): LIFECORE BIOMEDICAL; 3515 lyman blvd.; chaska MN 55318
• Manufacturer Contact: sharon spencer ; 50 technology drive; irvine, CA 92618 ; 9493985698
• MDR Report Key: 4852991
• MDR Text Key: 15392261
• Report Number: 1313525-2015-01653
• 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,health professional,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• 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: 60082L
• Device Lot Number: 025712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2014
• 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