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

Model Number 1MTEC30

Device Problems Crack (1135); Material Frayed (1262)

Patient Problem No Patient Involvement (2645)

Event Date 07/25/2018

Event Type  malfunction  

Manufacturer Narrative

Lot #: unknown, was not provided.Expiration date: unknown, as the lot number was not provided.Udi#: unknown, as the lot number was not provided.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.Device manufacture date: unknown, as the lot number was not provided.Attempts have been made to obtain missing information; however, the information is not available/has not been provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a 1mtec30 cartridge tip was found cracked/ frayed by the surgery technician prior to use.There was no patient contact.No additional information provided.

Manufacturer Narrative

Device available for evaluation: yes.Returned to manufacturer on: 08/15/2018.Device returned to manufacturer: yes.Device evaluation: the cartridge was returned in a plastic bag.The visual inspection does not reveal a molding defect.Traces of viscoelastic were observed at the cartridge tip.The cartridge is deformed (split).The reported complaint was verified.The cause of the reported issue of split tip could not be determined.However, the returned cartridge condition suggests that the cartridge tip could have been broken with the handpiece push rod.Labeling review: a review of the directions for use (dfu) was performed.The dfu adequately provides instructions, warnings, and precautions for the proper use and handling of the product.Based on the results of the investigation, no product deficiency was identified.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, INC.; santa ana CA 92705
• MDR Report Key: 7814163
• MDR Text Key: 118260698
• Report Number: 2648035-2018-01135
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• 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