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

Model Number 1MTEC30

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported during product handling and prior to insertion of the 1mtec30 cartridge model the cartridge was split.Through follow up, customer account provided additional information confirming the split was located at the cartridge tip and there was no iol product quality issue.There is no patient contact.No additional information was provided to johnson & johnson surgical vision.

Manufacturer Narrative

Device available for evaluation: yes, returned to manufacturer on: 01/18/2019.Device evaluation: a 1mtec30 cartridge was received inside a bag.The sample was observed under microscope and a scarce amount of viscoelastic residue was observed only in the cartridge tube.Directions for use state to fill the entire inside of the cartridge with viscoelastic.The cartridge tip and tube was observed with stress marks, a split was observed between the cartridge tube and tip.This condition could be caused by the delivery of the lens due to the scarce amount of viscoelastic used that could cause and extra force to be performed for the lens delivery.The complaint tip deformed was not verified in the return sample however a cartridge crack was observed.No product quality deficiency was identified.Manufacturing records review: during the manufacturing record review of the production order for this serial number, no product deficiency was identified.The documentation shows that the production order was manufactured and released according to specifications.Labeling review: the labeling review was completed and revealed that the directions for use (dfu) provide the customer with proper usage instructions and guidelines.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.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: 8273083
• MDR Text Key: 133931753
• Report Number: 2648035-2019-00118
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)191011(10)CD10744
• 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: 01/01/2005,11/06/2020

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: 10/11/2019
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CD10744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• 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: 01/07/2019
• Initial Date FDA Received: 01/24/2019
• Supplement Dates Manufacturer Received: 01/30/2019; 10/25/2020
• Supplement Dates FDA Received: 02/25/2019; 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1