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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 Bent; Positioning Failure; Failure to Deliver
Event Date 11/10/2015
Event Type  Malfunction  
Manufacturer Narrative

Implant date: not applicable; the lens was not implanted in the patient¿s eye. Explant date: not applicable; the lens was not implanted in the patient¿s eye. Concomitant medical products: zcb0000205 lens, serial number: (b)(4). All pertinent information available to abbott medical optics has been submitted.

 
Event Description

It was reported that the cartridge was bent and the lens touched the patient铠eye. Additional information confirmed that the lens was not inserted in the eye. The lens was stuck in the cartridge. Reportedly, there was no incision enlargement, no vitrectomy performed and no patient injury. The patient is doing well.

 
Manufacturer Narrative

The emeraldc30 cartridge is not recommended for use with a zcb00 one (1) piece iol. The emeraldc30 cartridge is the recommended cartridge for three (3) piece iols. The cartridge was return to the manufacturing site. Visual inspection revealed residues of viscoelastic solution and the intraocular lens was observed stuck in cartridge. Also, heavy dent/distortions were observed on cartridge tip. The complaint reported was verified. However use error may have contributed to the reported issue. Labeling review: 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 and the reported issue was verified. 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 Key5311116
Report Number2648035-2015-01326
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/25/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/18/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/21/2016
Device MODEL NumberEMERALDC30
Device Catalogue NumberEMERALDC30
Device LOT NumberCA04570
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/01/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/21/2015
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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