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

Model Number	ZXT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Halo (2227); No Code Available (3191)
Date of Event	04/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device cannot be completed.A review of the device/lot history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported zxt225 28.0 diopter intraocular lens (iol) was implanted in the patient¿s operative eye on (b)(6) 2018 and explanted on (b)(6) 2018 due to patient complaint of traceable halos.There was no required medical intervention, the zxt225 lens was replaced with a zct150 26.5 diopter iol, and patient outcome was reported as good.Through follow up, customer account provided additional information confirming there were no complications post lens exchange.No additional information was provided to johnson & johnson surgical vision.
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 SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 8072770
• Report Number: 9614546-2018-01081
• Device Sequence Number: 19424221
• Product Code: POE
• UDI-Device Identifier: 05050474605954
• UDI-Public: (01)05050474605954(17)220920
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2022
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U280
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 11/15/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1MTEC30 CARTRIDGE, LOT NUMBER UNKNOWN; 1MTEC30 CARTRIDGE, LOT NUMBER UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Date Report Sent to FDA: 01/01/2005