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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 +20. 0 diopter, serial number (b)(4); amo viscoelastic healon, lot number ub32345; non_amo viscoelastic, lot number 026254. (b)(6). (b)(4). 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 also 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.

 
Manufacturer Narrative

Device evaluation: the cartridge was received in a small sample collection container. Viscoelastics residues were detected on the cartridge tube. Visual inspection at 10x microscope magnification was performed. Stress marks in both sides of the cartridge tube and tip were observed which are typically caused and/or may appear by the passage of the iol through the cartridge. The cartridge was observed to be cracked, and tip was observed as deformed. There are no particle / debris detected on the return. The reported issue of tip deformed was verified. Manufacturing records review: the manufacturing records for the product were reviewed. The product was manufactured and released according to specifications. Labeling review: the directions for use (dfu) were reviewed. The dfu adequately provide instructions and precautions along with warnings for the proper use and handling of the device. Conclusion: 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.

 
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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 Key6235830
Report Number2648035-2017-00041
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/19/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/09/2017
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 Received01/25/2017
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

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