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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. EMERALD SURGICAL ADJUNCTS

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JOHNSON & JOHNSON SURGICAL VISION, INC. EMERALD SURGICAL ADJUNCTS Back to Search Results
Model Number EMERALDC30
Device Problem Device Contamination with Chemical or Other Material
Event Date 04/27/2018
Event Type  Malfunction  
Manufacturer Narrative

If implanted; give date: not applicable; the cartridge is not an implantable device. If explanted; give date: not applicable; the cartridge is not an implantable device. (b)(6). Attempts have been made to obtain further information; however, to date, no response has been received. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.

 
Event Description

It was reported that white powder/particulates came out of emerald cartridge lot # cc10459, while implanting a sensar 3 intraocular lens (iol) into the eye. Surgeon was able to remove the white powder/particulates through irrigation/aspiration (i/a). Per account, the problem was observed when the cartridge tip contacts the eye. The iol was not removed. There was no patient issue reported. No additional information provided.

 
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Brand NameEMERALD
Type of DeviceSURGICAL ADJUNCTS
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
santa ana CA 92705
Manufacturer (Section G)
JOHNSON & JOHNSON SURGICAL VISION, INC.
road 402 north, km 4.2
anasco industrial park, pob 14
anasco PR 00610
Manufacturer Contact
pamela mcclain
1700 east st. andrew place
santa ana , CA 92705
7142478243
MDR Report Key7546820
Report Number2648035-2018-00784
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,09/07/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/25/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date08/23/2018
Device MODEL NumberEMERALDC30
Device Catalogue NumberEMERALDC30
Device LOT NumberCC10459
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report TO Manufacturer01/10/2005
Date Manufacturer Received08/16/2018
Is this a Reprocessed and Reused Single-Use Device? No

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