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

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Date of event: unknown, not provided, but the best estimate date is during (b)(6) 2019.If explanted, give date: not applicable, remains implanted in the eye.Device evaluation: product testing could not be performed because the product was not returned as it remains implanted.The reported complaint was not confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.A search revealed no additional investigation requests for this production order number.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that patient underwent cataract surgery in (b)(6) 2019 for her both eyes.After the surgery she is experiencing halos and starburst.Her vision is good besides and uses glasses for close up vision.She reported this to her surgeon in (b)(6) 2019 and was told to see him next year.She saw the doctor in (b)(6) 2020 and a night test was done to evaluate her vision.However, she said the lights they used were not indicative of what she actually sees when she¿s driving.She stated that the halos and starbursts occur around any light source.It is severe enough to where she has stopped driving at night, out of concern she could easily get into an accident.In addition, she was told there was no scar tissue and that lasik would not help.She was prescribed glasses to help with the issue, but it doesn¿t work.Her doctor didn¿t advise her about how to improve the issue, but stated it is better than a cataract, and that he¿d see her next year.Additional information was received and it was learnt that doctor prescribed her with pilocarpine eye drops which lead to migraine and pain.It although temporarily helped with halos however migraine was very bad.She added that she cannot drive at all at night as the halos and starburst is very bad at night.Her day vision is good.She saw first symptom right away after the surgery when the patch was opened, on requesting information if the doctor discussed any plan for any intervention she stated that per doctor it is so risky to do anything so he has not yet discussed anything.This event will capture information for patient¿s right eye.A separate report is being submitted for patient¿s left eye.No further information provided.
Additional Manufacturer Narrative
Additional information: additional information was received and it was learnt that the patient was also experiencing glare.(b)(4).All pertinent information available to johnson and johnson surgical vision 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 (b)(4) and capa (b)(4).

• Brand Name: TECNIS SYMFONY
• 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: 9804073
• Report Number: 2648035-2020-00219
• Device Sequence Number: 643772
• Product Code: POE
• UDI-Device Identifier: 05050474579187
• UDI-Public: (01)05050474579187(17)230827
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2020
• 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: 08/27/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0245
• 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: 02/10/2020
• Supplement Date Received by Manufacturer: 03/20/2020; 10/25/2020
• Initial Report FDA Received Date: 03/08/2020
• Supplement Report FDA Received Date: 04/06/2020; 11/02/2020
• 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