• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS HEALON ENDOCOAT OVDS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT MEDICAL OPTICS HEALON ENDOCOAT OVDS Back to Search Results
Model Number VT585U
Device Problem Use of Device Problem (1670)
Patient Problem No Code Available (3191)
Event Date 03/03/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). If implanted; give date: not applicable. If explanted; give date: not applicable. (b)(4). All pertinent information available to abbott medical optics has been submitted.

 
Event Description

It was reported that a healon endocoat syringe popped off and patient lost zonules in the left eye. Reportedly, syringe guard was not used as instructed and the doctor had to use a capsular tension ring. No further information was provided.

 
Manufacturer Narrative

Device evaluation: complaint device was not returned for evaluation as it was reported as discarded by the customer. The manufacturing and receiving inspection records were reviewed. There were no deviations or comments regarding cannula attachment. Final product testing requires the connection of the cannula to the syringe for expelling product used in testing activities. The investigation shows that the (b)(4) syringes and cannulas used were found to be acceptable and that the final product lot met the product specifications.   a review of the complaints did not indicate any trend.   based on the investigation results, no root cause related to the manufacturing process could be identified.   all pertinent information available to abbott medical optics has been submitted.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 82
SE 751 82
Manufacturer Contact
pam mcclain
1700 east st. andrew place
santa ana, CA 92705
7142478243
MDR Report Key5540003
MDR Text Key41611618
Report Number3004750704-2016-00005
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
Type of Report Initial,Followup
Report Date 10/13/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/31/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date10/29/2017
Device MODEL NumberVT585U
Device Catalogue NumberVT585U
Device LOT Number025834
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 Manufactured10/30/2015
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: 03/31/2016 Patient Sequence Number: 1
-
-