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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
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/04/2017
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

As surgeon was applying viscoelastic the cannula reportedly popped off. When the surgeon inspected the device, the viscoelastic syringe did not have the threaded collar according to the report. There was no injury to the patient.

 
Manufacturer Narrative

The device was not returned to the manufacturer for evaluation. Therefore a product evaluation could not be conducted. A device history record (dhr) could not be performed as the lot number for the device was not provided. Based on the information available, the root cause of the reported event could not be conclusively determined.

 
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Brand NameOCUCOAT VISCOELASTIC
Type of DeviceAID, 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 Key7023301
MDR Text Key92646309
Report Number0001313525-2017-02834
Device Sequence Number1
Product Code LZP
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP860047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/12/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/10/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
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 Received04/02/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/10/2017 Patient Sequence Number: 1
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