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

Model Number	PCB00
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Failure to Eject (4010)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the product was returned.Visual inspection using magnification was performed to the returned sample: the plunger and pushrod were observed in advanced position.The pushrod was observed that overrides the lens in the cartridge.Residues of viscoelastic material was observed on cartridge.The cartridge tip was observed deformed.The lens was also observed damaged and stuck in cartridge.As part of the visual inspection, the preloaded device was disassembled to address the complaint issue reported.The plunger and pushrod were observed in good condition.The threads of the injector, upper and lower body of the device were correctly engaged and were in a good condition.No defects were observed in the lower body lid engage pin and rings.The condition in which the sample returned is consistent with a product that was handled and prepared for a surgical process.The complaint issue reported was not verified.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.The search revealed that no additional investigations were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that preloaded intraocular lens device had defective plunger.There was no patient contact.This was observed during handling prior to insertion.Additional information was received and it was learnt that tip was deformed.No further information provided.
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.; santa ana CA
• MDR Report Key: 8109332
• Report Number: 2648035-2018-01522
• Device Sequence Number: 2364105
• Product Code: HQL
• UDI-Device Identifier: 05050474558083
• UDI-Public: (01)05050474558083(17)191011
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020
• 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: 10/11/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 11/04/2020
• 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