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

Model Number EMERALDC30

Device Problem Failure to Eject (4010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Lot number: unknown, not provided.Expiration date: unknown, as lot number was not provided.Catalog#: a complete catalog number is unknown as the lot number was not provided.Udi#: a complete udi # is unknown as the lot number was not provided.Device manufacture date: unknown, as lot number was not provided.Attempts have been made to obtain missing information; however, to date a response has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that during advance of the intraocular lens (iol) it became stuck in the cartridge.Apparently the tech had an issue with loading the lenses, same patient.They complained of the lens getting stuck when advancing it.One of the lenses had patient contact and one did not.No further information was provided.

Manufacturer Narrative

Device evaluation: the lens was not returned; only the original folding carton and the empty tray of an emerald cartridge were received on 04/16/2019.Therefore, a product evaluation could not be performed; the reported issue could not be verified.A product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed no additional investigation request has been received for this production order number.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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, 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 (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: 8489564
• MDR Text Key: 141170551
• Report Number: 2648035-2019-00428
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/10/2020

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 Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: UNKNOWN
• 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: 03/12/2019
• Initial Date FDA Received: 04/05/2019
• Supplement Dates Manufacturer Received: 05/22/2019; 10/25/2020
• Supplement Dates FDA Received: 06/14/2019; 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ZA9003 LENS, SERIAL# (B)(4)