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

Model Number EMERALDC30

Device Problems Deformation Due to Compressive Stress (2889); Contamination /Decontamination Problem (2895); Failure to Eject (4010)

Patient Problem No Patient Involvement (2645)

Event Date 06/10/2019

Event Type  malfunction  

Manufacturer Narrative

Expiration date: unknown, as the lot number was not provided.Lot number: unknown, information not provided.Udi number: a partial udi number is known, as the lot number was not provided.If implanted, if explanted, give date: not applicable as this is not an implantable device.  device manufacture date: unknown as lot number was not provided.All pertinent information available to johnson and johnson surgical vision has been submitted.

Event Description

It was reported that lens got stuck in the cartridge.Reportedly the cartridge had piece of plastic blocking the opening as there was defect in the cartridge.Back up lens was opened, and surgery was completed successfully.This event was observed during handling prior to insertion.No further information provided.

Manufacturer Narrative

Device available for evaluation: yes, returned to manufacturer on: 7/2/2019.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.An ar40m lens box was received.There was inside a used emeraldc30 with a lens stuck inside.Scarce amount of viscoelastic residues were observed inside the device.The lens was observed stuck in the cartridge tube.This condition could be related to the scarce amount of viscoelastic used.The cartridge tip was observed deformed and damaged.This condition could be caused by the handpiece during handling.There was observed inside the cartridge tip dried viscoelastic residues.The complaint stuck in cartridge was verified in the returned sample, however could be related to the handling process.The complaints cartridge damaged and debris / particles were not verified in the returned sample.The complaint tip deformed was observed.A product quality deficiency was not identified.Manufacturing record review: the manufacturing record evaluation could not be performed since the lot number is unknown.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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-0148919 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: 8796886
• MDR Text Key: 151283730
• Report Number: 2648035-2019-00731
• 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: 01/01/2005,11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• 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: AR40M LENS SN: (B)(4); AR40M LENS SN: (B)(4)