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 Type  malfunction  

Manufacturer Narrative

Date of event: unknown, information not provided.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.Initial reporter name: unknown, information not provided (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the tip of the emeraldc30 cartridge was jagged.The issue was noted when the cartridge was taken out of the package.Implanting was not done with this cartridge and the procedure was completed successfully using a back up cartridge.There was no patient injury reported.No additional information was provided.

Manufacturer Narrative

Device available for evaluation? yes; returned to manufacturer on: 10/14/2019.Device returned to manufacturer? yes.Device evaluation: one used unit and one unopened/sealed unit was received.The unopened unit was evaluated for comparison purposes with the used unit, as per request.Visual inspection using magnification was performed.Used unit: the cartridge was observed with tip deformed, confirming the reported issue.One lens was observed stuck at the cartridge tube.Evidence of viscoelastic residues was observed in the cartridge tip, tube, wings and loading zone.The condition observed is consistent with a unit that has been damaged by the contact of the metal rod tip from the hand piece tool during use.The reported issue was confirmed on the return.However, there is no evidence to suggest that the complaint sample has been affected by the manufacturing process.No product deficiency was identified.Unopened new unit: visual inspection using magnification was performed.The cartridge tip was observed in good condition and form.No tip defects were observed.This new sample returned for comparison, met product specification.No product deficiency was identified.Manufacturing record review: the manufacturing process record was evaluated, and the devices were manufactured within specifications.The units were released according to specification with the product intended use as required.There were no issues identified associated to the complaint issue reported.The search in complaint system revealed no additional investigation request (ir) received for this lot.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: 9212909
• MDR Text Key: 166355960
• Report Number: 2648035-2019-01118
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)200103(10)CE00075
• 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
• Report Date: 01/01/2005,11/09/2020

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: 01/03/2020
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• 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: 09/26/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 10/29/2019; 10/25/2020
• Supplement Dates FDA Received: 11/21/2019; 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TECNIS LENS, MODEL ZA9003, LOT: UNKNOWN