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

Model Number 1MTEC30

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

If implanted, give date: not applicable as this is not an implantable device.If explanted, give date: not applicable as this is not an implantable device.(b)(6).All pertinent information available to johnson and johnson surgical vision has been submitted.

Event Description

It was reported that the tip of the 1mtec30 cartridge was deformed.The issue was noted upon taking the cartridge out of the package and there was no patient contact reported.The procedure was completed successfully with the back up.There was no patient injury reported.No additional information was provided.

Manufacturer Narrative

Device available for evaluation: yes; returned to manufacturer on: 10/10/2019.Device returned to manufacturer: yes.Device evaluation: the product associated to the complaint was received.The cartridge was received on the tray packaged in a plastic bag.The tyvek lid was received as well.There are traces of viscoelastics at the cartridge tube indicating it was prepared for insertion.The cartridge tip is cracked and deformed.The damaged on the cartridge is compatible with damage that could be caused by a defective hand piece and/or wrong positioning of the cartridge.The reported issue was verified.Based on the product evaluation there is no indication of a product quality deficiency.Manufacturing records review: the manufacturing records were evaluated, and non- conformance reports (nc) were found associated to this production order number.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search in complaint system revealed that no other investigation request (irs) has been received for this lot.Conclusion: based on the investigation results, there is no indication of a product quality deficiency.All pertinent information available to johnson and 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.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9154385
• MDR Text Key: 166175751
• Report Number: 2648035-2019-01071
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)200307(10)CE02517
• Combination Product (y/n): Y
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/09/2020

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: 03/07/2020
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CE02517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• 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: 09/10/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 10/21/2019; 10/25/2020
• Supplement Dates FDA Received: 11/15/2019; 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1