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

Model Number EMERALDC30

Device Problem Crack (1135)

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

Event Date 11/28/2020

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: 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 the cartridge is not an implantable device.If explanted, give date: not applicable, as the cartridge is not an implantable device.Phone: (b)(6).Device manufacture date: unknown as lot number was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that one of the cartridge was damaged at the tip and the other one burst as the iol passed opening at the folding part, cracking or breaking partially or totally.There was patient contact with cartridge which was observed during implantation/application.No further information provided.This report captures the event of tip damaged.

Manufacturer Narrative

Device evaluation: product testing could not be performed since the product was not returned for evaluation.However, due to an increase in emerald cartridges customer complaints related to device codes dc-cartridge crack and dc-wing broken were observed for the month of december 2020, capa010442 was created for further investigation and the implementation of corrective and preventive actions.The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing record evaluation could not be performed because the lot number of the complaint product is unknown.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified as the complaint product was no returned and the lot number of the complaint product is unknown.All pertinent information available to johnson & 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: 11120068
• MDR Text Key: 240646861
• Report Number: 2648035-2021-00002
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• 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
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1