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

Model Number EMERALDC30

Device Problem Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Manufacturer Narrative

Gender/sex: unknown, information not provided.Date of event: unknown, information not provided.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, give date: not applicable as this is not an implantable device.If explanted, give date: not applicable as this is not an implantable device.The device was not returned for analysis and there was no lot number reported for this device; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.Device manufacture date: unknown as lot number was not provided.An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision has been submitted.

Event Description

It was reported that white muk, waxy, soft plastic material shearing off the emerald series cartridges.That they often get this type of muk when injecting a 3-piece sensar intraocular lens (iol) through an emeraldc30 cartridge.On (b)(6) 2019, the reporter indicated that they checked an empty cartridge and scratched the inner surface but there was no powder.They thought this could be dried viscoelastic on the pusher device that could have dried up if not cleaned well and autoclaved.However, on this day, they checked the pusher device and it appears shining bright and clean.There is no inflammation and it gets washed off easily.The reporter noted that they do not see this problem when they insert this iol without the injector system in a manual 6mm small incision surgery.The user reported that they use methycellulose most often but in this case, they used sodium hyaluronate which involved an (b)(6) year old child with cataract and they were worried to see this issue happening with that case.The user thinks that there is lubricant in the cartridges more than they are used to seeing.They do not think it would create a problem if left behind but they still remove it.They indicated that they have seen some cases where there is a greasy looking plaque like substance and it always disappears and they been told that it is a lubricant.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 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: 9177460
• MDR Text Key: 166181531
• Report Number: 2648035-2019-01088
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• 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?: No
• 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: 3-PIECE SENSAR LENS
• Patient Age: 8 YR