MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS SYMFONY TORIC; MULTIFOCAL IOLS

Model Number	ZXT300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is (b)(6) 2018.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that a model zxt300 +15.0 diopter intraocular lens was explanted from the patient¿s right eye.An incision enlargement was required, but no vitrectomy or sutures.The replacement lens was a model zxt225 +17.0 diopter.Patient outcome was noted as patient tolerated the procedure well.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 1/23/2019.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The product was received in a ziplock bag.Visual inspection with the unaided eye shows the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.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 review.The product was manufactured and released according to specifications.The search revealed that no similar complaints 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 & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in mdr follow-up #1 the following additional information was known, however was inadvertently not provided.It was learnt that the explant was performed because of patient experiencing blurry vision.A model zxt225 +17.0 diopter was used as the replacement lens.There was no patient injury, nor medical or surgical intervention required during the explant procedure.Date of birth: (b)(6) 1952.Patient code 2137 ¿ blurry vision.All pertinent information available to johnson and johnson surgical vision has been submitted.
Additional Manufacturer Narrative
Correction: in follow up 2, deate received by mfr was incorrectly populated as 1/15/2019, the correct date received by manufacturer is 2/6/2019.All pertinent information available to johnson and johnson surgical vision 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 SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 8247012
• Report Number: 9614546-2019-00043
• Device Sequence Number: 2125447
• Product Code: POE
• UDI-Device Identifier: 05050474606289
• UDI-Public: (01)05050474606289(17)210708
• 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
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/06/2020
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2021
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 02/03/2019; 02/03/2019; 02/06/2019; 10/25/2020
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 02/06/2019; 02/06/2019; 02/07/2019; 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005