• 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 Problem Contamination (1120)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Age/date of birth: unknown/ not provided. Sex/gender: unknown/ not provided. Date of event: unknown, not provided, but the best estimate date is during 2018. Expiration date: unknown, as the lot number was not provided. Lot number: unknown, information not provided. Udi number: unknown, as the lot number was not provided. Catalog number: unknown, as the lot number was not provided. 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. Concomitant products: iol serial unknown. Device manufacture date: unknown, as the lot number was not provided. Device evaluation: product evaluation could not be performed since the product was not returned for evaluation. According to the action/evaluation description section, no product will return. Therefore, the reported issues could not be verified, and product quality deficiency could not be determined. Manufacturing record review: manufacturing record review could not be performed because the lot number of the complaint product is unknown. The complaint occurrences per lot/batch review could not be performed because the serial number of the complaint product is unknown. Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
Event Description
Report of ar40e intraocular lenses (iols) being defective described as having a film on the edge that is visible when the doctor looked through the microscope after implantation. It was stated during follow-up that suspect must be the cartridge. The tech loads the lens and it is in the cartridge and not visible at that point. It¿s there when the lens is ejected. Further follow-up was done to ask for clarification and also obtain more information but since event has been from a while back already no specific information was 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 Key8958879
MDR Text Key156496163
Report Number2648035-2019-00958
Device Sequence Number1
Product Code KYB
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K961242
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,11/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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? No
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received10/25/2020
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

Patient Treatment Data
Date Received: 09/04/2019 Patient Sequence Number: 1
Treatment
AR40E, IOL SERIAL NUMBER UNKNOWN
-
-