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

Model Number EMERALDC30

Device Problems Break (1069); Failure to Eject (4010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.If implanted, give date: not applicable, as product is not an implantable device.If explanted, give date: not applicable, as product is not an implantable device.Device evaluation: the complaint product was received in march 19, 2020.Visual inspection performed under microscope.The lens was received too, and it was stuck in the cartridge.A small amount of lubricating material residues can be observed in the cartridge.No damaged/defect was observed in the cartridge, it looks in good condition.The lens was not removing from the cartridge because removing it could cause damage to the lens and/or haptics.Due to the condition in which the sample returned the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no additional complaints were received from this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a za9003 intraocular lens (iol) had a haptic bent while being inserted into the eye.It was stated that the lead haptic touched the patient¿s eye.It was also noted that the iol was stuck in an emeraldc cartridge.The patient was alright and the product will be returned.No other information was provided.This mdr report pertains to the suspect emeraldc cartridge.A separate vmsr report will be submitted for the suspect iol.

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 (b)(4).

• 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: 9911046
• MDR Text Key: 185958677
• Report Number: 2648035-2020-00308
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)200301(10)CE02379
• Combination Product (y/n): Y
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CE02379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• 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
• Treatment: ZA9003, SERIAL NUMBER (B)(4); ZA9003, SERIAL NUMBER (B)(4)