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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS HEALON OVDS

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ABBOTT MEDICAL OPTICS HEALON OVDS Back to Search Results
Model Number HEALON GV
Device Problems Disconnection (1171); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

Date of event: unknown, not provided. If implanted, give date: not applicable as this is not an implantable device. If explanted, give date: not applicable as this is not an implantable device. Phone number: (b)(6). All pertinent information available to abbott medical optics has been submitted.

 
Event Description

It was reported that there was viscoelastic leakage between the vial and the needle. Reportedly, the cannula was disconnected from the syringe during surgical procedure. No patient injury was reported. The same issue was reported for 4 devices with lot number uc31663. Therefore 4 mdrs will be submitted. This report represents the first of the 4 reports.

 
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Brand NameHEALON
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 Key7181462
MDR Text Key96943600
Report Number3004750704-2018-00010
Device Sequence Number1
Product Code LZP
Combination Product (Y/N)N
Reporter Country CodeSE
PMA/PMN NumberP810031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/22/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/10/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date07/31/2020
Device MODEL NumberHEALON GV
Device Catalogue Number10200014
Device LOT NumberUC31663
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/09/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/31/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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