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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 Problems Use of Device Problem (1670); Device Handling Problem (3265)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Age/date of birth: unknown, not provided. Gender/sex: unknown, not provided. Date of event: unknown, not provided. If implanted; give date: na (not applicable). If explanted; give date: na (not applicable). All pertinent information available to abbott medical optics has been submitted.

 
Event Description

It was reported that during use of the healon endocoat, the fulcrum (finger rest) came loose. No information was provided that indicated a patient injury occurred. According to a previous report by the doctor, the white fulcrum piece that came loose was examined, and it was not snapped into place. Upon examination, the piece was able to be snapped back onto the viscoelastic and was not damaged. The doctor stated that he never looks at which way the fulcrum is placed on the viscoelastic device. The assistant puts it in my hand while i am looking through the scope. No further information provided.

 
Manufacturer Narrative

Device evaluation the device was not returned to the manufacturer for evaluation. Visual inspection could not be performed. Batch record review determined components were inspected, evaluated, and accepted per lifecore specification. The root cause of this incident does not appear to be related to the manufacturing process. Record review determined there were no deviations or comments regarding finger grip detachment. The root cause of this complaint is not likely related to the manufacturing process. Record review determined components were inspected, evaluated, and accepted per lifecore specifications. The investigation indicates that the lot meets the product specification. Lifecore will continue monitoring for any trend related to this type of complaint based on the investigation results there is no indication of a product quality deficiency. 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.
amo uppsala
rapsgatan
uppsala 751 8 2
SE 751 82
Manufacturer Contact
pam mcclain
1700 east st. andrew place
santa ana, CA 92705
7142478243
MDR Report Key5542876
MDR Text Key41719524
Report Number3004750704-2016-00007
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 COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/13/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/01/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date10/31/2016
Device MODEL NumberVT585U
Device Catalogue NumberVT585U
Device LOT Number025682
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 Received09/30/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/31/2014
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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