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

Model Number	PCB00
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If explanted, give date: not applicable, as the lens remains implanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that plastic from the cartridge of a pcb00 intraocular lens insertion system came out into the patient's operative eye with the intraocular lens during implantation.The lens was kept in the operative eye and the plastic was removed by irrigation and aspiration.There was no incision enlargement, no vitrectomy, and no sutures used.Reportedly, there was no patient injury and the patient is doing fine post-operatively.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes, returned to manufacturer on: 04/30/2019.Device returned to manufacturer: yes.Device evaluation: the plunger was observed in advanced position.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 device was open for inspection.No assembly error and/or defect were observed in the preloaded device related to manufacturing process.The foreign material in question was not found.According to the customer the plastic piece was removed by irrigation and aspiration with no complications.The device was opened and no damaged components were identified.The reported issue could not be verified.No product deficiency was identified.There is no evidence to suggest that the complaint sample has been affected by the manufacturing process, no other physical damage is observed on the sample.The reported issue was not verified.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 revealed that no other complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed, the dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.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 (b)(4) 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: 8494224
• Report Number: 2648035-2019-00439
• Device Sequence Number: 2594157
• Product Code: HQL
• UDI-Device Identifier: 05050474558168
• UDI-Public: (01)05050474558168(17)210726
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/26/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 05/08/2019; 10/25/2020
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 06/03/2019; 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005