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

Model Number EMERALDC30

Device Problem Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that model emeraldc30 unfolder cartridge had irregular tip with non-cylindrical edges as this alleged issue which caused injury of the incision during surgery.No additional information provided.

Manufacturer Narrative

Additional information: based on new information received, there was a 5 minute delay in procedure and there was a threading of the main incision as incision enlargement was performed.Product will not be returned as it is discarded by the surgery center.The following fields have been updated accordingly: age/date of birth: (b)(6), sex/gender: male.The intraocular lens (iol) is not returning for evaluation as it is discarded; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: in review, it was noted that an update of initial code (b)(4) for unspecified injury to incision enlargement and that threading of the incision (sutures) was not captured in the supplemental mdr report#1; therefore, this information is being captured in this supplemental report#2.The following fields were updated accordingly: (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-(b)(4) and capa-(b)(4).

• Brand Name: EMERALD
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 8093577
• MDR Text Key: 128011029
• Report Number: 2648035-2018-01503
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)181121(10)CC13800
• Combination Product (y/n): Y
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/01/2005,11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2018
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 10/26/2018
• Initial Date FDA Received: 11/21/2018
• Supplement Dates Manufacturer Received: 11/19/2018; 01/08/2019; 10/25/2020
• Supplement Dates FDA Received: 12/10/2018; 01/22/2019; 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR