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

Model Number	PCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient contact reported.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the cartridge tip of the preloaded delivery system (model pcb00) was broken during handling, but prior to use.No patient contact was reported.A backup pcb00 lens (same diopter size) was implanted successfully during the same procedure.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 8/22/2018.Device returned to manufacturer? yes.Sample was received.Visual inspection using magnification was performed.Plunger and pushrod were observed in the advanced position.Lack of viscoelastic material was observed on cartridge.Lens was observed damaged and stuck in cartridge.The leading haptic was observed exposed at the cartridge tip.The cartridge tip was also observed deformed.The condition in which the sample returned is consistent with a product that was handled and prepared for a surgical process.The complaint was confirmed, cartridge tip was damaged.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.A search revealed no additional investigation request for this production order.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.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.; santa ana CA 92705
• MDR Report Key: 7730569
• Report Number: 2648035-2018-01057
• Device Sequence Number: 19173786
• Product Code: HQL
• UDI-Device Identifier: 05050474558175
• UDI-Public: (01)05050474558175(17)210227
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 11/02/2020
• 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: 02/27/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 08/23/2018; 10/25/2020
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 09/20/2018; 11/02/2020
• 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