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U.S. Department of Health and Human Services

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

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JOHNSON AND 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 05/09/2018
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 a contact name was not provided. (b)(6). All pertinent information available to johnson and johnson surgical vision, inc. Has been submitted.

 
Event Description

It was reported that fibrous foreign matter was found on the intraocular lens (model za9003 +22. 0 diopter) after insertion into the patient's eye. Reportedly the lens was removed and replaced, during the same surgical procedure, with a pcb00 lens +19. 5 diopter. No patient injury was reported. No further information was provided. Two mdrs will be submitted for this event. This report is to record the cartridge; a separate report will be filed for the lens.

 
Manufacturer Narrative

Device evaluation: the cartridge was not returned at the manufacturing site; therefore product testing could not be performed. A video of the procedure was provided and it was evaluated. Something at the edge of the intraocular lens was observed. The customer's reported complaint was confirmed but it was not possible to determine what the object was or the source. During manufacturing, each cartridge is 100% inspected under 10x microscope; therefore it is very unlikely that a fiber particle the size shown in the video was present on the cartridge at the time of the sealing process. A product deficiency could not be identified. Manufacturing records review: the manufacturing records for the cartridge were reviewed. The product was manufactured and released according to specification. A search revealed that no additional complaints for this order number have been received. 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 johnson and johnson surgical vision, inc. Has been submitted.

 
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Brand NameEMERALD
Type of DeviceSURGICAL ADJUNCTS
Manufacturer (Section D)
JOHNSON AND JOHNSON SURGICAL VISION, INC.
santa ana CA
Manufacturer (Section G)
JOHNSON AND JOHNSON SURGICAL VISION, 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 Key7576857
Report Number2648035-2018-00840
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/26/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/07/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date08/02/2018
Device MODEL NumberEMERALDC30
Device Catalogue NumberEMERALDC30
Device LOT NumberCC09438
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/02/2017
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: 06/07/2018 Patient Sequence Number: 1
Treatment
ZA9003 LENS, SERIAL NUMBER (B)(4)
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