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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 Problems Difficult or Delayed Positioning; Positioning Failure ; Device Operates Differently Than Expected
Event Type  Malfunction  
Manufacturer Narrative

Date of event: unknown, not provided. 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. Concomitant medical products: za9003 lens, serial number (b)(4); injector, model and serial number unknown. All pertinent information available to johnson and johnson surgical vision, inc. Has been submitted.

 
Event Description

It was reported that during the implantation of the intraocular lens (model za9003, +17. 0 diopter) the plunger of the injector disengaged after the lens was already advanced to the point of being ready to insertion. No medical or surgical intervention was required. Reportedly, the lens was partially delivered into the eye. No further information was provided.

 
Manufacturer Narrative

This supplemental report pertains to emeraldc30 cartridge; device available for evaluation? yes. Returned to manufacturer on: 5/14/2018. Device returned to manufacturer? yes. Device evaluation: the cartridge was not received. Only za9003 lens was returned. The reported complaint cannot be confirmed since the cartridge was not returned. Manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specification. There was no discrepancy found during the review. A search revealed no additional investigations requested for this production order. Labeling review: the dfu was reviewed. The dfu adequately provides instructions and precautions for the proper use and handling of the product. Conclusion: based on the investigation results there is no indication of a product quality deficiency. All pertinent information available to johnson & 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 Key7509378
Report Number2648035-2018-00697
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial
Report Date 06/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/11/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberEMERALDC30
Device Catalogue NumberEMERALDC30
Device LOT NumberCC14048
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/14/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2018
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

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