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

Model Number	ZXT375
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	10/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.If explanted, give date: not applicable, remains implanted in the eye.(b)(4).All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that patient had moderate glare and halos while driving at night.In the non-directed ocular visual symptoms, the subject had no complaints.The monocular (uncorrected distance visual acuity) ucdva - ocular dexter (od) 20/20; oculus sinister (os) 20/20.Monocular (best corrected distance visual acuity) bcdva ¿ od 20/20; os 20/20.The first eye od had surgery on (b)(6) 2019 and was implanted with a 20.5 d model zxt375 iol, serial number (b)(4).The second eye os had surgery on (b)(6) 2019 and was implanted with a 20.0 d model zxt225 iol, serial number (b)(4).Additional information was received, and it was learnt that patient had reported same issues at 1 month visit as well.There is no surgical intervention planned.Patient¿s daily activities are severely affected.This report will capture information for patient¿s right eye.Another report is being submitted for patient¿s left eye.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 SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9489134
• Report Number: 9614546-2019-01119
• Device Sequence Number: 2079914
• Product Code: POE
• UDI-Device Identifier: 05050474606982
• UDI-Public: (01)05050474606982(17)211030
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020
• 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: 10/30/2021
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U205
• 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: 11/22/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 11/05/2020
• 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: Other
• Date Report Sent to FDA: 01/01/2005