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

Model Number EMERALDC30

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2017

Event Type  malfunction  

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 device evaluation: the cartridge was not returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the cartridge were reviewed.During the manufacturing process the operators check the neck, tube and tip areas for cracks.They also check the tip for any melting, roughness, dent, bent tip or smash condition.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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 and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that during the implantation of the intraocular lens (iol) a burr was noticed on the cartridge.Reportedly, the leading haptic touched the patient's operative eye.Additional information was received and it was learnt that there was an imperfection on the cartridge tip.No incision enlargement, no vitrectomy was performed, no sutures were used and no patient injury post-op was reported.No further information was provided.

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 (b)(4) and capa:(b)(4).

• Brand Name: EMERALD
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7751846
• MDR Text Key: 116070589
• Report Number: 2648035-2018-01092
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)180713(10)CC08494
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2018
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CC08494
• 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: 07/26/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LENS ZA9003, SERIAL NUMBER (B)(4).; LENS ZA9003, SERIAL NUMBER (B)(4).
• Patient Age: 56 YR