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

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Date of Event	05/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, as the lens is still implanted.Device evaluated by mfr: 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, 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
The patient reported being moderately bothered by halos and starbursts in the 4-month study visit.The patient indicated that driving at night has significantly interfered with daily activities.Visual acuity was 20/25 in both eyes and at the 4-month study visit the patient's best corrected distance vision was 20/20 in both eyes.Reportedly, there was no patient injury.The patient has a dry eye syndrome called meibomian gland dysfunction (mgd) and had a lipiflow treatment at the end of the 3-month visit.At this time, the lens remains implanted.The patient has completed the study on (b)(6) 2019.No additional information was provided to johnson & johnson surgical vision.The patient had bilateral lenses implanted.This report will capture the lens implanted in the patient's left eye.A separate report will be filed for the right eye.
Additional Manufacturer Narrative
Additional information and corrected data: in reviewing the initial mdr, it was noticed that the following information was inadvertently not included and was reported incorrectly; therefore, it is captured in this supplemental report: other relevant history, including preexisting medical conditions: was updated accordingly to capture patients preexisting medical condition meibomian gland dysfunction (mgd).Device code: 2993.Patient code -3191 starbursts.All pertinent information available to johnson & 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 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: 8658649
• Report Number: 3011852734-2019-00115
• Device Sequence Number: 16706135
• Product Code: POE
• UDI-Device Identifier: 05050474605176
• UDI-Public: (01)05050474605176(17)220918
• 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): 11/12/2020
• 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: 09/18/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U185
• 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: 05/03/2019
• Supplement Date Received by Manufacturer: 06/06/2019; 10/25/2020
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 06/28/2019; 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005