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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS HEALON ENDOCOAT OVDS

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ABBOTT MEDICAL OPTICS HEALON ENDOCOAT OVDS Back to Search Results
Model Number VT585U
Device Problem Detachment Of Device Component (1104)
Patient Problem No Patient Involvement (2645)
Event Date 07/14/2016
Event Type  Malfunction  
Manufacturer Narrative

Udi#: unknown, since product lot# was not provided. Age/date of birth: unknown/not provided. Gender/sex: unknown/not provided. Lot number: unknown/not provided. Catalog #: unknown as lot number was not provided. Expiration date: unknown as lot number was not provided. If implanted; give date: unknown/not provided. Healon endocoat is a non-implantable dispersive device. If explanted; give date: not applicable. Device manufacture date: unknown as lot number was not provided. All pertinent information available to abbott medical optics has been submitted.

 
Event Description

It was reported that while preparing healon for use, the finger rest came off of the syringe, and could not be re-attached. There was no patient contact. No further information was provided.

 
Manufacturer Narrative

Recall: corrected to z-0530-2015. All pertinent information available to abbott medical optics has been submitted.

 
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Brand NameHEALON ENDOCOAT
Type of DeviceOVDS
Manufacturer (Section D)
ABBOTT MEDICAL OPTICS
santa ana CA
Manufacturer (Section G)
ABBOTT MEDICAL OPTICS INC.
rapsgatan
uppsala 751 8 2
SE 751 82
Manufacturer Contact
pam mcclain
1700 east st. andrew place
santa ana, CA 92705
7142478243
MDR Report Key5873716
MDR Text Key52431288
Report Number3004750704-2016-00015
Device Sequence Number1
Product Code LZP
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP110007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 08/16/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/12/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberVT585U
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2016
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
Removal/Correction NumberZ-0530-2015

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