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

Model Number EMERALDC30

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 04/01/2019

Event Type  malfunction  

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.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that model emeraldc30 cartridge tip seems to be wider than normal.There was no patient involvement.No additional information provided.

Manufacturer Narrative

Additional information indicated that the aperture, or the internal space of the cartridge, is not of adequate size and not open enough, that it is thicker on this cartridge; therefore, it is creating a pressure on the lens to pass or exit through the cartridge.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Device available for evaluation? yes; returned to manufacturer on: 10/24/2019.Device returned to manufacturer? yes.Device evaluation: the sample received was not in its original package.Visual inspection using magnification was performed to the returned sample and residue of lubricant material was observed on the cartridge.One of the cartridge wings was observed broken.The cartridge tip was observed slightly deformed and is consistent when the lens passes through the cartridge.No other defect was observed to the cartridge and cartridge tip.The condition in which the sample was returned is consistent with a cartridge that was handled and prepared for surgical process.The complaint issue reported could not be verified.However, tip deformed and wing broken were identified on sample returned.Manufacturing record review: the manufacturing process record was evaluated, and the devices were manufactured within specifications.There is no associated deviation or non-conformity report found in the manufacturing record review (mrr).The units were released according to specification with the product intended use as required.A search revealed eight additional investigations requests for this production order number; however, no product deficiency was identified in the investigations.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 (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: 8571228
• MDR Text Key: 143889016
• Report Number: 2648035-2019-00522
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)190924(10)CD10258
• Combination Product (y/n): Y
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/01/2005,11/11/2020

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: 09/24/2019
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CD10258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• 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: 04/02/2019
• Initial Date FDA Received: 05/01/2019
• Supplement Dates Manufacturer Received: 04/23/2019; 10/30/2019; 10/25/2020
• Supplement Dates FDA Received: 05/21/2019; 11/22/2019; 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1