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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

If implanted, give date: not applicable as this is not an implantable device. If explanted, give date: not applicable as this is not an implantable device. Concomitant medical products: intraocular lens (iol) za9003 +22. 0 diopter, serial number (b)(4); amo viscoelastic healon, lot number ub32345; non_amo viscoelastic, lot number 026254. (b)(6). 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. It was also reported 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 which 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 returned at the manufacturing site for evaluation. Visual inspection at 10x microscope magnification showed no viscoelastic residue on the cartridge. Stress marks on both sides of the cartridge tube and tip were observed which are typically caused and/or may well appear by the pass of the iol through the cartridge. The cartridge was observed cracked on the tip and tube. The cartridge tip was observed deformed. No debris/particles were detected with the returned device. The customer's reported complaint for debris/particles was not verified, however tip deformed was verified. 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.

 
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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 Key6235827
Report Number2648035-2017-00040
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/17/2017
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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