MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION PLATINUM 1 SERIES; SURGICAL ADJUNCTS

Model Number 1MTEC30

Device Problem Failure to Eject (4010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2018

Event Type  malfunction  

Manufacturer Narrative

Lot number: unknown, information not provided.Udi number: unknown, as the lot number was not provided.If implanted; give date: n/a (not applicable) as the product is not implantable.If explanted; give date: n/a (not applicable) as the product is not implantable.Device manufacture date: unknown, as the lot number was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported when inserting zxr00 with 20.0 diopter intraocular lens (iol) into the patient's operative eye the lens got stuck with the 1mtec30 cartridge, there was patient contact with the lens and cartridge, and the procedure was completed successfully using lens with the same model and diopter.Through follow up, customer account provided additional information confirming the lens was partially delivered into the eye when stuck in cartridge event occurred.There is no serious patient injury, no medical complications, and there was no surgical intervention.No additional information was provided to johnson & johnson surgical vision.

Manufacturer Narrative

Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing record review could not be performed since the cartridge lot number was not provided.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions, precautions and warning for the proper use and handling of the product.As a result of the investigation there is no indication of a product malfunction or 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.

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: PLATINUM 1 SERIES
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 7987639
• MDR Text Key: 124492544
• Report Number: 2648035-2018-01363
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(10)UNKNOWN
• Combination Product (y/n): Y
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• 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: ZXR00 IOL SN: (B)(4)