MAUDE Adverse Event Report: JOHNSON AND 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	Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Date of Event	08/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explant date: if explanted; give date: n/a (not applicable).The intraocular lens remains implanted.(b)(4).Reason for non-evaluation: it was indicated that the device remains implanted and 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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient was implanted with two tecnis symfony intraocular lenses (iol) and experienced profound starbursts and halos almost immediately after surgery.The patient indicated that he continues to have severe problems with night driving and that he sees concentric circles around traffic lights radiating outward about four or five times the diameter of the light.He indicated that he sees large halos around street lights, traffic lights, the moon, in the theater and any light in the dark.The patient also mentioned that he sees very distracting and large starbursts from oncoming headlights, so large that they sometimes block out most of his lane.The patient reported that he was involved in a traffic accident where he hit another car.The surgeon performed a yag laser capsulotomy on the left eye shortly after surgery, as the patient had developed a secondary cataract/ pco (posterior capsule opacification).However, the customer mentioned that the yag laser capsulotomy did not change anything.The patient has tried yellow anti-glare night driving glasses, but they have been not helpful.The doctor suggested a yag on the right eye although he did not see any pco.The patient is skeptical about having the yag performed on the right eye.A procedure for the right eye has not been scheduled.No additional information was provided to johnson and johnson surgical vision, inc.Note: 2 mdr¿s will be submitted, one for each affected eye.This mdr captures the information pertaining to the right 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.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7708257
• Report Number: 9614546-2018-00698
• Device Sequence Number: 789659
• Product Code: POE
• UDI-Device Identifier: 05050474605756
• UDI-Public: (01)05050474605756(17)220613
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020
• 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: 06/13/2022
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U180
• 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: 06/24/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 10/30/2020
• 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