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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH + LOMB OCUCOAT VISCOELASTIC AID, SURGICAL, VISCOELASTIC

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BAUSCH + LOMB OCUCOAT VISCOELASTIC AID, SURGICAL, VISCOELASTIC Back to Search Results
Model Number CC050S
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2019
Event Type  Malfunction  
Manufacturer Narrative

The product is not available for analysis, as it was discarded. Investigation is underway.

 
Event Description

It was reported that during use with the patient, liquid was coming upstream of the needle, as if the needle was unset. Another of the same device was used. There was no patient impact. Though requested, no additional information has been provided. The product is not available for analysis, as it was discarded.

 
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Brand NameOCUCOAT VISCOELASTIC
Type of DeviceAID, SURGICAL, VISCOELASTIC
Manufacturer (Section D)
BAUSCH + LOMB
1400 n goodman
rochester NY 14609
Manufacturer (Section G)
LIFECORE BIOMEDICAL
3515 lyman blvd.
chaska MN 55318
Manufacturer Contact
stephanie anastasiou
21 n. park place
clearwater, FL 33759
7277246659
MDR Report Key9516995
MDR Text Key175879191
Report Number0001313525-2019-00221
Device Sequence Number1
Product Code LZP
Combination Product (Y/N)Y
Reporter Country CodeNC
PMA/PMN NumberP860047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,11/27/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/24/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCC050S
Device Catalogue NumberCC050S
Device LOT Number027130
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report TO Manufacturer01/10/2005
Date Manufacturer Received01/15/2020
Is this a Reprocessed and Reused Single-Use Device? No

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