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U.S. Department of Health and Human Services

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

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LIFECORE BIOMEDICAL AMVISC PLUS AID SURGICAL VISCOELASTIC Back to Search Results
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.

 
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Brand NameAMVISC PLUS
Type of DeviceAID 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 Key4840743
MDR Text Key5873358
Report Number1313525-2015-01574
Device Sequence Number1
Product Code LZP
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP810025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/13/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/10/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2016
Device MODEL Number60081L
Device LOT Number025712
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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