MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS

Model Number PCB00

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 08/09/2019

Event Type  malfunction  

Manufacturer Narrative

If implanted; give date: n/a (not applicable).The preloaded inserter is not an implantable device.If explanted; give date: n/a (not applicable).The preloaded inserter is not an implantable device; therefore, not explanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a pointy burr sticking out from the tip of a preloaded inserter system (pcb00) and the doctor decided not to use it.There was no patient contact and no additional information was provided.

Manufacturer Narrative

Device available for evaluation: yes, returned to manufacturer on: 9/13/2019.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site.The plunger was observed in partially advanced position and the plunger was not lock as required per dfu.The pcb00 device was observed under microscope and scarce amount of viscoelastic were observed at the cartridge.Dfu states to completely fill the viewing window of the pcb00 with ovd.The lens was observed stuck in cartridge and the cartridge have the tip deformed.The reported issue tip deformed was confirmed but it could not be determined if the condition observed is related to manufacturing process as the reported device was handling and use in a surgical procedure.Based on the product returned evaluation a product quality deficiency or product malfunction could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.Historical data analysis: a search of complaints revealed no other complaint has been received for this production order number.Conclusion: as a result of the investigation there is no indication of a quality product deficiency and the reported issue could not be verified.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: TECNIS ITEC PRELOADED 1-PIECE IOL
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9108950
• MDR Text Key: 159937931
• Report Number: 2648035-2019-01031
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558274
• UDI-Public: (01)05050474558274(17)220708
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• 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: 01/01/2005,11/10/2020

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: 07/08/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• 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: 08/28/2019
• Initial Date FDA Received: 09/24/2019
• Supplement Dates Manufacturer Received: 09/26/2019; 10/25/2020
• Supplement Dates FDA Received: 10/02/2019; 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1