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

Model Number	PCB00
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.If implanted, if explanted, give date: not applicable, as lens was not implanted.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that preloaded pcb00 device did not have an intraocular lens in the cartridge when surgeon went to implant.There was patient contact with the cartridge.Reportedly sutures were required during this procedure.No further information provided.
Additional Manufacturer Narrative
Device available for evaluation; returned to manufacturer on: 8/1/2019.Device evaluation: the product was returned to the manufacturing site for evaluation.The returned pcb00 device was received in a plastic bag.The plunger was observed in advanced position.The plunger was gently pulled back and found locked and functional.The pcb00 device was observed under microscope and traces of viscoelastic and/or balanced salt solution were observed at the tip of the cartridge.Dfu z311134p dfu, tecnis itec preload pcb00, 1st revision a states to completely fill the viewing window of the pcb00 with ovd.The lens was observed stuck and overridden at the cartridge.There were no damages observed on the assembly.The reported complaint issue was not verified.No product quality deficiency was identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints related to this production order was conducted in the complaint system.The search revealed no additional investigation requests (ir) received for this production order.Conclusion: 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.
Additional 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: TECNIS ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8863126
• Report Number: 2648035-2019-00851
• Device Sequence Number: 16850023
• Product Code: HQL
• UDI-Device Identifier: 05050474558373
• UDI-Public: (01)05050474558373(17)211024
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 08/09/2019; 10/25/2020
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 08/22/2019; 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005