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

Model Number EMERALDC30

Device Problem Contamination (1120)

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

Event Date 12/19/2019

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: 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.Phone: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that white powder was found in the cartridge at the of implantation of the lens.The cartridge tip made contact with the eye.No additional information was provided.

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.

Manufacturer Narrative

Section d10.Device available for evaluation? yes; returned to manufacturer on: 1/24/2020.Section h3.Device returned to manufacturer? yes.Device evaluation: the cartridge was received in its original tray with tyvek lid.The cartridge has traces of what appears to be viscoelastics and/or balanced salt solution.The white powder (as described by the customer) could not be found on the returned cartridge or cartridge tray.Upon evaluation of the video provided by the customer, it can be observed what appears to be the particles of interest as they are expelled thru the tip of a cartridge at ten seconds from its start.Removal by aspiration of starts at the minute 1:37.The apparent particles composition is unknown as none was identified for analysis.The devices preparation for insertion are not available in the video to be evaluated.Therefore, the reported issue could not be confirmed to be associated to the cartridge manufacturing process; a product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search revealed no additional investigation requests (ir) has been received for this batch.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.

• 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: 9580510
• MDR Text Key: 180152896
• Report Number: 2648035-2020-00045
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)200415(10)CE03684
• 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: 01/01/2005,11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2020
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CE03684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• 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