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	05/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable as the device remains implanted.(b)(4).Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints have been received for this production order number.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient is included in a clinical study of (b)(6).The patient was implanted a bilateral zxt150 intraocular lens (iol).It was learnt that at about the 6th month of follow-up, the subject noted: very bothered by halos: difficult to see clearly when headlights are facing toward me / also have halos in my home around light sources like clock radio light.Very bothered by starbursts: seeing clearly when headlights are coming at me at night.Very bothered by glare related to scattered light: very bothered on a two lane road.Moderately bothered by poor low light vision: reading menus or small print the symptoms do interfere with daily activities.The iols still remain implanted in the subject in both eyes with no intervention planned.Pre-operative best corrected visual acuity (bcva): right eye (od) 20/40, left eye (os) 20/50 6 month bcva od 20/20 os 20/20.No other information was provided.This mdr report pertains to the right eye (od).A separate report will be submitted for the left eye (os).
Additional Manufacturer Narrative
Additional information: additional information was received for the subject's 1-year visit.At one-year, the subject's monocular undercorrected distance visual acuity (ucdva): 20/25 od, 20/20 os; best corrected distance visual acuity (bcdva): 20/20 od, 20/20 os.The subject reported being extremely bothered by halos (night time around any light in or outside), extremely bothered by starbursts (night time driving and general lighting at night), extremely bothered by multiple or double vision (focusing), extremely bothered by sensitivity to light (headlights/driving), extremely bothered by glare related to scattered light (night driving), extremely bothered by poor low light vision (trying to focus).Based on the additional information received additional patient 3191-diplopia is being provided.No surgical intervention is planned.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: 8975178
• Report Number: 9614546-2019-00839
• Device Sequence Number: 3294631
• Product Code: MFK
• UDI-Device Identifier: 05050474605244
• UDI-Public: (01)05050474605244(17)211010
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• 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: health professional,study,use
• 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: 10/10/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U220
• 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: 08/14/2019
• Supplement Date Received by Manufacturer: 06/24/2020; 10/25/2020
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 06/26/2020; 11/13/2020
• 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