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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH + LOMB AMVISC VISCOELASTIC

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BAUSCH + LOMB AMVISC VISCOELASTIC Back to Search Results
Device Problems Break (1069); Detachment Of Device Component (1104); Fluid Leak (1250)
Patient Problem Eye Injury (1845)
Event Date 03/07/2017
Event Type  Malfunction  
Event Description

Amvisc syringe hub leaked and broke off, coming in contact with the ocular lens and causing some displacement of zonules.

 
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Brand NameAMVISC
Type of DeviceVISCOELASTIC
Manufacturer (Section D)
BAUSCH + LOMB
bridgewater NJ 08807
MDR Report Key6463268
MDR Text Key72124688
Report NumberMW5068921
Device Sequence Number1
Product Code LZP
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PHARMACIST
Type of Report Initial
Report Date 04/04/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/04/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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