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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH + LOMB AMVISC PLUS VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC

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BAUSCH + LOMB AMVISC PLUS VISCOSURGICAL DEVICE AID, SURGICAL, VISCOELASTIC Back to Search Results
Model Number 60081L
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/03/2018
Event Type  Malfunction  
Manufacturer Narrative

Investigation of this event is in progress. A follow-up report will be submitted upon completion of the investigation.

 
Event Description

It was reported that when surgeon went to inject medication the cannula slipped off the syringe. The physician had her hand on cannula so there was no patient injury according to the report. Additional information has been requested bus has not been received.

 
Manufacturer Narrative

Investigation of this event is in progress. A follow-up report will be submitted upon completion of the investigation.

 
Manufacturer Narrative

The device was not returned to bausch + lomb; therefore, a product evaluation could not be performed. The device history records were reviewed and there were no discrepancies or unusual finding that relate to the reported issue. Based on the information available, the root 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)
BAUSCH + LOMB
1400 north goodman street
suite 1
rochester NY 14609
Manufacturer (Section G)
LIFECORE BIOMEDICAL
3515 lyman blvd.
chaska MN 55318
Manufacturer Contact
tes proud
1400 north goodman street
rochester, NY 14609
5853388549
MDR Report Key7246304
MDR Text Key99211216
Report Number0001313525-2018-00039
Device Sequence Number1
Product Code LZP
Combination Product (Y/N)Y
Reporter Country CodeUS
PMA/PMN NumberP810025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 01/09/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/06/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date04/30/2019
Device MODEL Number60081L
Device LOT Number026747
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 Received04/08/2018
Is this a Reprocessed and Reused Single-Use Device? No

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