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

Model Number	ZXT150
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Date of Event	09/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, as lens remains implanted.Other: the device remains implanted therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot 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 at one month visit a clinical patient reported being very bothered by halos.It was also stated that the patient cannot drive at night.Visual acuity- 20/15 right eye (od); 20/20 left eye (os).No intervention planned.The pre-operative best corrected distance visual acuity (bcdva): 20/25 od, 20/30 os.However, the subject returned on an unscheduled visit.Although bcdva was 20/20 for both eyes (ou), yttrium aluminum garnet (yag) capsulotomy was performed for ou which was because of posterior capsule opacificaton (pco) ou.The subject reported being extremely bothered by halos-drive at night; very bothered by starbursts- drive at night; extremely bothered by glare- computer work, driving at night, glare bothers the patient often when walking around in my home because of light from windows.No other information was provided.This mdr report pertains to the left eye (os).A separate report will be submitted for the right eye (od).
Additional Manufacturer Narrative
Additional information: at 6 month visit, the patient has best corrected distance visual acuity (bcdva) of 20/15 for both eyes (ou).The subject reported being extremely bothered by halos-drive at night; very bothered by starbursts- drive at night; extremely bothered by glare- computer work, driving at night, glare often when walking around at home because of light from windows.It was stated that the visual symptoms are debilitating and were reported as an adverse event/serious injury.No intervention is planned at this time.The subject was considering an explant, but has changed their mind.All pertinent information available to johnson & johnson surgical vision, inc.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: 11181426
• Report Number: 9614546-2021-00003
• Device Sequence Number: 14005932
• Product Code: POE
• UDI-Device Identifier: 05050474605275
• UDI-Public: (01)05050474605275(17)230703
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: 07/03/2023
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U235
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 06/08/2021
• 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
• Patient Age: 74 YR