• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

JOHNSON & JOHNSON SURGICAL VISION, INC. EMERALD SURGICAL ADJUNCTS Back to Search Results
Model Number EMERALDC30
Device Problems Failure to Unfold or Unwrap; Failure to Eject
Event Date 04/24/2019
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, give date: not applicable as this is not an implantable device.   if explanted, give date: not applicable as this is not an implantable device.   device manufacture date: unknown as lot number was not provided. Device evaluation: product testing could not be performed because the product was not returned. The reported complaint was not confirmed. Labeling review: the directions for use (dfu) were reviewed. The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device. Conclusion: as a result of the investigation, there is no indication of a product quality deficiency. Attempts have been made to obtain missing information; however, to date, no response has been received. All pertinent information available to johnson and johnson surgical vision has been submitted.

 
Event Description

It was reported that when attempting to inject the intraocular lens into the patient¿s left eye the lens would not advance then would not unfold. There was patient contact. There was no patient injury. Patient was doing fine. Additional information was received, and it was learnt that the lens contacted the patient however the lens was not fully inserted, removed and replaced. There was no incision enlargement, no sutures and no vitrectomy required. No further information provided.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8638008
Report Number2648035-2019-00594
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,05/23/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/23/2019
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? 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 Received04/24/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-