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

Model Number EMERALDC30

Device Problem Crack (1135)

Patient Problem No Code Available (3191)

Event Date 05/30/2019

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).All pertinent information available to johnson and johnson surgical vision has been submitted.

Event Description

It was reported that 3 cartridges of the same lot cracked.Additional information was received, and it was learnt that the whole cartridge cracked at the fold upon closure, so advancement and insertion of the lens was not possible.As a result, the patient was left aphakic.The surgeon was trying to use the cartridge with a model za9003 lens to place in the sulcus.There was no patient involvement with the device.This report will capture the event for #2 of 3 cartridges.A separate report is being filed for each reported cartridge.No further provided.

Manufacturer Narrative

Device evaluation: product testing could not be performed because the product was not returned.The reported complaint was not confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.The product was manufactured and released according to specifications.Conclusion: 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 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-010215.

• Brand Name: EMERALD
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8774586
• MDR Text Key: 150541576
• Report Number: 2648035-2019-00713
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)191109(10)CD12043
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2019
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CD12043
• 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
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LENS MODEL ZA9003, SN: UNKNOWN; LENS MODEL ZA9003 SN: UNKNOWN
• Patient Outcome(s): Required Intervention