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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 Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2017
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 the finger grips came off the plunger while advancing in the eye.The first viscoelastic did not cause any issues.The second viscoelastic did not cause any issues, however, the syringe broke in the surgeon's hand while advancing.This report refers to the second viscoelastic used.
 
Manufacturer Narrative
The device was returned to b+l.Visual inspection found the glass rim of the syringe barrel is broken off and is loose around the plunger rod shaft.The finger grip is still attached to the rim.The device history record was reviewed and there were no discrepancies or unusual findings that relate to the reported issue.Based on the current information the root cause of the event could not be conclusively determined.
 
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Brand Name
AMVISC PLUS VISCOSURGICAL DEVICE
Type of Device
AID, SURGICAL, VISCOELASTIC
Manufacturer (Section D)
BAUSCH + LOMB
1400 north goodman street
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 Key7166070
MDR Text Key96467582
Report Number0001313525-2018-00008
Device Sequence Number1
Product Code LZP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P810025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 12/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2019
Device Model Number60081L
Device Lot Number026792
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/06/2017
Initial Date FDA Received01/04/2018
Supplement Dates Manufacturer Received04/08/2018
Supplement Dates FDA Received05/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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