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

Model Number EMERALDC30

Device Problems Crack (1135); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 10/04/2018

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).Device evaluation: the cartridge was returned at the manufacturing site and it was evaluated.Residue of viscoelastic material was observed on the cartridge.The cartridge tip was observed deformed.No damage was observed to the cartridge wings.The condition of returned cartridge is consistent with a product that was handled and prepared for a surgical process.Based on the investigation, there is no indication of quality deficiency.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search revealed that revealed no additional investigation requests for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.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.

Event Description

It was reported that after folding the intraocular lens (iol) into the cartridge, the wings were difficult to close and the cartridge broke.It was also stated that the tip seemed sharp.No patient involvement was reported.Through follow-up, it was learnt that the customer correctly loaded the za9003 intraocular lens into the cartridge and the adequate amount of ovd (ophthalmic viscosurgical device) was used during preparation of the device.The cartridge was returned at the manufacturing site and the cartridge tip was observed deformed.No further 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.

• Brand Name: EMERALD
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 8146078
• MDR Text Key: 129756389
• Report Number: 2648035-2018-01598
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)190821(10)CD09313
• 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
• Report Date: 01/01/2005,11/04/2020

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: 08/21/2019
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CD09313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• 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: 11/13/2018
• Initial Date FDA Received: 12/10/2018
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ZA9003 LENS, SERIAL NUMBER UNKNOWN; ZA9003 LENS, SERIAL NUMBER UNKNOWN.