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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
If implanted; give date: n/a (not applicable). The cartridge is not an implantable device. If explanted; give date: n/a (not applicable). The cartridge is not an implantable device; therefore, not explanted. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
Event Description
Reportedly, the surgeon noticed a burr on the end of the emeraldc30 cartridge tip during insertion of the intraocular lens (iol) into the patient¿s eye. The procedure was completed successfully without harm to the patient. No additional information was provided.
 
Manufacturer Narrative
Device available for evaluation? yes. Returned to manufacturer on: 10/8/2018. Device returned to manufacturer? yes. Device evaluation: visual inspection shows the cartridge tip was deformed and cracked. However, the condition of the returned lens indicates that it was previously handled and prepared for a surgical process. Based on the analysis, there is no indication of a product quality deficiency. The reported issue of tip deformed was verified. Manufacturing record review: manufacturing record was reviewed and revealed that the product was manufactured and released according to specifications. Labeling review: the labeling review was completed and revealed that the directions for use(dfu) provide the customer with proper usage instructions and guidelines. Complaint history: a search of complaints revealed no other complaints have been received for this production order number. 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
MDR Report Key7912420
MDR Text Key121854045
Report Number2648035-2018-01262
Device Sequence Number1
Product Code KYB
Combination Product (y/n)Y
PMA/PMN Number
K961242
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 01/01/2005,11/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/02/2019
Device Model NumberEMERALDC30
Device Catalogue NumberEMERALDC30
Device Lot NumberCD02658
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2018
Was the Report Sent to FDA? No
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received10/25/2020
Is This a Reprocessed and Reused Single-Use Device? No

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