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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS EMERALD SURGICAL ADJUNCTS

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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 +25. 0 diopter, serial number (b)(4); amo viscoelastic healon, lot number ub32345; non amo viscoelastic, lot number 026254. (b)(6). Device evaluation: the cartridge was returned at the manufacturing site for evaluation. Visual inspection at 10x microscope magnification showed viscoelastic residues inside the cartridge tube/tip and on the wings, indicating that the device was handled and prepared for surgical use. Stress marks in both sides of the cartridge tube and tip were observed which are typically caused and/or may well appear by the pass of the intraocular lens (iol) through the cartridge. The cartridge's tip was not observed deformed. A crack from the cartridge tip across the tube section was observed. No debris or particle matters were detected on the returned sample. The customer's report of cartridge crack was confirmed. 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. They heard the cartridge cracking. The cartridge channel broke open inside the patient¿s eye. The surgeon had to use a second instrument to advance the lens into the implant position and also to extract the cartridge. Reportedly, a small piece of particle matter was also noticed and was aspirated following the lens implant. There were no adverse effects. 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.

 
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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 Key6235862
Report Number2648035-2017-00047
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 Date07/11/2017
Device MODEL NumberEMERALDC30
Device Catalogue NumberEMERALDC30
Device LOT NumberCB35883
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 Manufactured07/11/2016
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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