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

Model Number	PCB00
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable as lens was not implanted.If explanted, give date: not applicable as lens was not explanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that when using pcb00 32.5 diopter the plunger would not turn and would not advance.There was patient contact but there were no complications.The procedure was completed successfully with a backup lens of the same model and diopter.Reportedly, the patient is doing fine.
Additional Manufacturer Narrative
Device available for evaluation: yes, device returned to manufacturer on: 05/23/2019.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection showed the plunger and pushrod were observed in advanced position.Residues of viscoelastic material was observed on cartridge.The delivery was completed, and a piece of the lens came out.The condition in which the sample was returned is consistent with a product that was handled and prepared for a surgical process.The complaint issue was verified.However, there is no evidence to suggest that the complaint sample has been affected by the manufacturing process.Based on the analysis product quality deficiency could not be determined manufacturing records review: the manufacturing records for the preloaded lens wree reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no additional complaint was received from this production order number.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.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be 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: 8634294
• Report Number: 2648035-2019-00588
• Device Sequence Number: 2017408
• Product Code: HQL
• UDI-Device Identifier: 05050474558519
• UDI-Public: (01)05050474558519(17)210501
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2020
• 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: 05/01/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 06/03/2019; 10/25/2020
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 06/28/2019; 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005