MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. PLATINUM 1 SERIES; 1MTEC30

Model Number 1MTEC30

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2019

Event Type  malfunction  

Manufacturer Narrative

Device available for evaluation: yes.Device returned to manufacturer on: 3/15/2019.Device evaluation: the product was returned to the manufacturing site for evaluation.The 1mtec30 cartridge was received with a tip deformed, broken; no other physical damage is observed on the cartridge.A small amount of viscoelastics is observed at the cartridge, no extra plastic piece was identified.No lens was returned.Tip deformed was verified.However, the reported device problem code of cartridge damaged, stuck in cartridge was not verified.Manufacturing records review: the manufacturing records for the cartridge were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that one other complaint was received for this production order number.No product deficiency was identified.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was initially reported that a 1mtec30 platinum 1 series cartridge had a rough spot or extra plastic piece and would not allow the lens to advance while attempting to insert it into the operative eye.Follow-up was done to get clarification on the location of the cartridge damage but the customer was unable to provide any more information.The investigation results on the cartridge were subsequently received and it was reported that the tip was deformed.

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: 1MTEC30
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8502453
• MDR Text Key: 142196144
• Report Number: 9614546-2019-00323
• Device Sequence Number: 1
• Product Code: KYB
• 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
• Report Date: 01/01/2005,11/10/2020

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: 06/19/2019
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CD07073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• 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: 03/15/2019
• Initial Date FDA Received: 04/11/2019
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IOL MODEL ZXR00, SERIAL# (B)(6).