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 12/12/2018

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 tip of model emeraldc30 cartridge looked melted and the lens could not enter the tip of the cartridge.Through follow-up, the surgeon noticed the damaged tip prior to insertion.As a result, cartridge was changed and the lens was implanted normally.It was also noted that there was no affect on the patient nor outcome.No additional information provided.

Manufacturer Narrative

Device available for evaluation?: yes, returned to manufacturer on: 03/06/2019.Device returned to manufacturer?: yes.Device evaluation: the cartridge was received on march 06, 2019 and was observed under microscope.The tip showed dents and was deformed.This condition could be caused by the handpiece during the loading process.The directions for use (dfu) states to insert the unfolder emerald series cartridge into the unfolder emerald series handpiece, taking care not to damage the cartridge tip.Residue was observed on the wings.The complaint was verified; however, it cannot be related to the manufacturing process.During the manufacturing process the operators verify the neck, tube and tip areas for cracks, stress marks, flashes and protuberances.The customer's reported event could not be verified.Manufacturing record evaluation: the manufacturing records for the cartridge were reviewed.The product was manufactured and released according to specification.No non-conformance reports (nc's) and no exemption report (er's) were found associated to this production order.A search revealed that no similar/additional complaints for this order number have been received.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.Conclusion: based on the manufacturing records review, historical complaint review, analysis of the return and non-conformance/capa review there is no indication of a product malfunction or 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 nr-0148919 and capa-010215.

• Brand Name: EMERALD
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 8251523
• MDR Text Key: 133199270
• Report Number: 2648035-2019-00072
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)190502(10)CD04983
• Combination Product (y/n): Y
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/06/2020

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: 05/02/2018
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CD04983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• 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: 12/19/2018
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: 04/04/2019; 10/25/2020
• Supplement Dates FDA Received: 05/03/2019; 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1