MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. EMERALDC30; SURGICAL ADJUNCTS

Model Number EMERALDC30

Device Problem Failure to Eject (4010)

Patient Problem No Code Available (3191)

Event Date 08/01/2019

Event Type  Injury  

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.The device was not returned for analysis.There was no model/lot/serial number reported for this device; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that on (b)(6) 2019 while inserting a model za9003 intraocular lens (iol) the lens did not discharge out of the cartridge during the initial procedure.An incision enlargement was required, and a second lens, same model/diopter was implanted.Customer indicated that product is not available for return.On (b)(6) 2019 a pars plana vitrectomy was required.The lens remains implanted, and no further complications have been reported.No additional information was provided.This report captures the event associated with the cartridge.A separate report is being submitted to capture the event associated with the second lens.

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-0148919 and capa-010215.

• Brand Name: EMERALDC30
• 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: 9158802
• MDR Text Key: 161338849
• Report Number: 2648035-2019-01074
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(10)UNKNOWN
• 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
• Report Date: 01/01/2005,11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ZA9003 INTRAOCULAR LENS, SERIAL# (B)(4)
• Patient Outcome(s): Required Intervention