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U.S. Department of Health and Human Services

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

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

 
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Brand NameAMVISC PLUS VISCOSURGICAL DEVICE
Type of DeviceAID, 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 Key4852991
MDR Text Key15392261
Report Number1313525-2015-01653
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,HEALTH PROFESSIONAL,USE
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/20/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/16/2015
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 Number60082L
Device LOT Number025712
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/10/2014
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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