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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 Problems Deformation Due to Compressive Stress ; Contamination / decontamination Problem ; Failure to Eject
Event Date 06/10/2019
Event Type  Malfunction  
Manufacturer Narrative

Expiration date: unknown, as the lot number was not provided. Lot number: unknown, information not provided. Udi number: a partial udi number is known, as the lot number was not provided. If implanted, if explanted, give date: not applicable as this is not an implantable device.   device manufacture date: unknown as lot number was not provided. All pertinent information available to johnson and johnson surgical vision has been submitted.

 
Event Description

It was reported that lens got stuck in the cartridge. Reportedly the cartridge had piece of plastic blocking the opening as there was defect in the cartridge. Back up lens was opened, and surgery was completed successfully. This event was observed during handling prior to insertion. No further information provided.

 
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Brand NameEMERALD
Type of DeviceSURGICAL ADJUNCTS
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
1700 e st andrew place
santa ana CA 92705
Manufacturer (Section G)
JOHNSON & JOHNSON SURGICAL VISION, INC.
road 402 north, km 4.2
anasco industrial park
anasco PR 00610
Manufacturer Contact
somyata nagpal
1700 east st. andrew place
santa ana , CA 92705
7142478200
MDR Report Key8796886
Report Number2648035-2019-00731
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,08/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberEMERALDC30
Device Catalogue NumberEMERALDC30
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/16/2019
Is The Reporter A Health Professional? No
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 Received07/26/2019
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/17/2019 Patient Sequence Number: 1
Treatment
AR40M LENS SN: (B)(4)
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