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

Model Number	PCB00
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; not applicable as there was no patient contact reported.If explanted; not applicable as there was no patient contact reported.(b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
A report was received that there was an issue with a model pcb00 intraocular lens (iol).The bezel plastic tip had a protruding edge.The doctor observed the problem when was preparing to implant.There was no patient involvement.
Additional Manufacturer Narrative
Device available for evaluation: yes, returned to manufacturer on: 05/09/2019.Device returned to manufacturer: yes.Device evaluation: the returned pcb00 (preloaded lens device) was received on 05/09/2019 in the original folding carton.The cartridge component was observed correctly engaged into lower body of the pcb00 device.No trace of viscoelastics was observed in the pcb00 insertion device.The lens was stuck at the cartridge tip.The cartridge tip was deformed.The deformation observed on the tip could be associated with a dent.The reported issue was verified.Based on the visual evaluation of the returned unit, it could not be determined that the cause of the issue reported was related to the manufacturing process since there are indications the unit was handled and prepared for lens insertion at the surgical stage.A product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no additional 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 quality deficiency.All pertinent information available to johnson and 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: 8591903
• Report Number: 2648035-2019-00553
• Device Sequence Number: 2169601
• Product Code: HQL
• UDI-Device Identifier: 05050474558205
• UDI-Public: (01)05050474558205(17)210102
• Combination Product (Y/N): Y
• Initial Reporter Country: ES
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 05/21/2019; 10/25/2020
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 06/14/2019; 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