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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 Collapse; Melted
Event Date 03/02/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Age/date of birth: unknown, not provided. Sex/gender: unknown, not provided. If implanted, give date: not applicable for cartridge. If explanted, give date: not applicable for cartridge. Telephone number: (b)(6). All pertinent information available to abbott medical optics has been submitted.

 
Event Description

It was reported that during insertion of a ar40e intraocular lens (iol), emeraldc30 cartridge was noted crushed and melted and the cartridge caused damage to the iol. The ar40e iol was replaced with another lens. There was no damage or injury to the patient. No further information was provided.

 
Manufacturer Narrative

Device evaluation: the complaint device was returned to the manufacturer for evaluation and visual inspection was performed at 10x microscope magnification. According to the visual inspection viscoelastic residues were observed inside the cartridge tube/tip, indicating the device was handled and prepared for surgical use. Also, stress marks in both sides of the cartridge tube and tip was observed which are typically caused and/or may well appear by the pass of the iol thru the cartridge. The tip of the cartridge was observed deformed confirming the reported issue. Therefore, the reported complaint of tip deformed was confirmed. Manufacturing record review and related document revealed that the product was manufactured and released according to specification. During the manufacturing process, inspections are performed to ensure no cracks or stress marks in the neck, tube and tip areas. Additional inspections verify no bubbles in the tube, in the hinge area or loading zone and check tip for any melting, roughness, dent, bent tip or smash condition. A review of complaints revealed no other complaint for this lot number have been received. A historical complaint data review was performed and results did not identify a product deficiency. Labeling review: the directions for use (dfu) was reviewed. The dfu adequately provides instructions for the proper use and handling of the cartridge. Based on the manufacturing record review, analysis returned product, historical complaint review, and labeling review, there is no indication of a product malfunction or product quality deficiency. Device was returned to manufacturer for evaluation. Device available for evaluation - yes. Returned to manufacturer on june 08, 2016. Device returned to manufacturer ¿ yes. 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 Key5685932
Report Number2648035-2016-00819
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/20/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/27/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date03/12/2016
Device MODEL NumberEMERALDC30
Device Catalogue NumberEMERALDC30
Device LOT NumberCA01645
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/08/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/12/2015
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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