MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. 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	08/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The intraocular lens (iol) is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending 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 that a study patient complained of very bothersome halos and moderately bothersome starbursts causing difficulty with driving post operatively.Best corrected distance visual acuity (bcdva): 20/20 od (right eye).Best corrected distance visual acuity 20/10 os (left eye).There are no plans for additional treatment.There was no reported patient complications and/or related injury.No further information provided.Patient had bilateral lens implants.This report is for the right eye.A second report will be submitted for the left eye.
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.
Additional Manufacturer Narrative
Additional information was received, and it was learnt that the patient returned for 1-year visit on (b)(6) 2020 and reported that patient was experiencing slightly bothered halos and starburst as the patient can¿t look at stars and enjoy stargazing.Monocular ucdva (uncorrected distance visual acuity): 20/20 ¿ right eye and 20/15 ¿ left eye.Bcdva (best corrected distance visual acuity): 20/20 ¿ right eye and 20/15- left eye.No further information provided.All pertinent information available to johnson and johnson surgical vision has been submitted.

• 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: 9096421
• Report Number: 9614546-2019-00882
• Device Sequence Number: 16819307
• Product Code: POE
• UDI-Device Identifier: 05050474605732
• UDI-Public: (01)05050474605732(17)220607
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2020
• 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: 06/07/2022
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U170
• 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: 08/26/2019
• Supplement Date Received by Manufacturer: 05/29/2020; 10/25/2020
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 06/23/2020; 11/10/2020
• 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
• Patient Age: 64 YR
• Date Report Sent to FDA: 01/01/2005