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

Model Number EMERALDC30

Device Problems Material Discolored (1170); Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a streaky residue was visible on the backside of the intraocular lens (iol) after using the emeraldc30 cartridge.This residue could not be removed.No patient impact reported or expected.Additional information was received and it was learnt that the streaks were visible right after the implantation of the za9003 lens, located centrally on the back side of the iol and could not be washed off.Several cases (10-15 circa) occurred over the last weeks in (b)(6) 2018.Reportedly, the issue was with the cartridge lot cd04786.No issues with the new lots of cartridges.No further information was provided.

Manufacturer Narrative

Based on new information, lot cd04788 is the correct lot number.Therefore, the following have been updated accordingly: lot#: cd04788, udi #: (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Device available for evaluation: yes, returned to manufacturer on: 12/15/2018.Device returned to manufacturer: yes.Device evaluation: thirty-four (34) unused and sealed emeraldc30 cartridges, lot number cd04788, were received.The cartridges were evaluated under magnification.No molding defects were observed.The cartridges were folded at the complaint handling laboratory; no issue was detected.The reported issue was not verified.A product quality deficiency could not be determined.No particle nor debris was observed on the cartridges.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed no additional investigation request for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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 nr-0148919 and capa-010215.

• Brand Name: EMERALD
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 8158850
• MDR Text Key: 130343085
• Report Number: 2648035-2018-01619
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)190424(10)CD04786
• 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,Followup
• Report Date: 01/01/2005,11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2019
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CD04788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2018
• 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: ZA9003 LENSES, SERIAL NUMBERS UNKNOWN