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

Model Number 1MTEC30

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown, 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; therefore, not explanted.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the tip of model 1mtec30 cartridge was crushed.Procedure was completed successfully with the back-up.It was noted also that there was no patient injury.No additional information was provided.

Manufacturer Narrative

Device available for evaluation: yes, returned to manufacturer on: 2/6/2019, device returned to manufacturer: yes.Device evaluation: a total of 28 cartridge units were received at manufacturing site.One (1) opened emeraldc30 cartridge and twenty-seven (27) unopened cartridges returned for investigation.Visual inspection using magnification was performed.Open cartridge was observed loaded with iol.Visual inspection using magnification was performed.The lens was observed stuck at the tube section.Evidence of viscoelastic residues was observed in the cartridge tube, tip, wings, and loading zone.The cartridge tip was observed deformed.No broken tip was observed on the return.Based on the evidence observed this cartridge has been handled and prepared for surgical use.There is no evidence to suggest that the complaint samples have been affected by the manufacturing process.No product deficiency was identified.The twenty-seven unopened cartridges were observed using magnification and no tip defects and/or broken tip were observed.All 27 units were observed in good condition.The reported issue was not confirmed.No product deficiency was identified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed no additional investigation request for this production order.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.

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 (b)(4) 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: 8211797
• MDR Text Key: 131901371
• Report Number: 2648035-2019-00009
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)190626(10)CD07330
• 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,foreig
• 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

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2019
• Device Model Number: 1MTEC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CD07330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• 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