• 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 EMERALD SURGICAL ADJUNCTS

  • 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 EMERALD SURGICAL ADJUNCTS Back to Search Results
Model Number EMERALDC30
Device Problems Break; Crack; Stretched
Event Date 12/14/2016
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: intraocular lens (iol) za9003 +20. 5 dioptre, serial number (b)(4); amo viscoelastic healon, lot number ub32157; non amo viscoelastic, lot number 026254. (b)(6). Device evaluation: the emeraldc30 cartridge was returned to the manufacturing site for evaluation. Visual inspection at 10x microscope magnification showed evidence of viscoelastic ovd (ophthalmic viscosurgical device) residue inside the cartridge tube/tip, indicating that the device was handled and prepared for surgical use. The cartridge tip was observed deformed. No cracks were observed. Manufacturing records review: the manufacturing records for the cartridge were reviewed. During the manufacturing process the operators check the neck, tube and tip areas for cracks. No cracking or stress marks are allowed. They also check the tip for any melting, roughness, dent, bent tip or smash condition. The product was manufactured and released according to specification. Labeling review: the directions for use (dfu) were reviewed. The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device. As a result of the investigation there is no indication of a product quality deficiency. All pertinent information available to abbott medical optics has been submitted.

 
Event Description

It was reported that during the implantation of an intraocular lens (iol), the surgeon noticed under the microscope that the tip of the cartridge had a deformed shaft and it began to stretch and crack as the lens advanced through it. Reportedly, the doctor also noticed that a piece of the cartridge tip was missing. No injury to the patient's eye and no surgical or medical intervention was required. The patient's outcome was reported being as expected. No further information was provided.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEMERALD
Type of DeviceSURGICAL ADJUNCTS
Manufacturer (Section D)
ABBOTT MEDICAL OPTICS
santa ana CA
Manufacturer (Section G)
ABBOTT MEDICAL OPTICS INC.
road 402 north, km 4.2
anasco industrial park, pob 14
anasco PR 00610
Manufacturer Contact
pam mcclain
1700 east st. andrew place
santa ana , CA 92705
7142478243
MDR Report Key6235866
Report Number2648035-2017-00048
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 01/09/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/10/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date04/25/2017
Device MODEL NumberEMERALDC30
Device Catalogue NumberEMERALDC30
Device LOT NumberCB31019
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/29/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/25/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-