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	Visual Disturbances (2140); Dizziness (2194); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date unknown, information provided states (b)(6) 2020.Explant date: not applicable as the lens has not been explanted.Device evaluation: product testing could not be performed as the product was not returned.The reported event could not be verified and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no other complaints for this order number have been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.(b)(4).
Event or Problem Description
It was reported that the patient had undergone bilateral intraocular lens (iol) implants.The patient is experiencing light sensitivity, and halos at night.Additionally, when using the computer, the patient experiences dizziness and flutter.The patient explained that his symptoms are in both eyes and they began in late (b)(6) 2020.Follow-up it was learned the patient is not taking any medication for his symptoms.The patient¿s eyes are light blue.The patient explained that he has always been sensitive to light even before the iols were implanted.Prior to the lens implants, light from his bedroom window bothered him even with his eyes closed.He must put a pillow over his face.He can¿t watch television in the dark, he must turn on all the lights.Also, when he works on his computer and then gets up and goes to the kitchen, the lights in the kitchen make him dizzy.He has led lights throughout his house which he now turns all the way down, that helps a little bit.His light sensitivity is about 50% more than it was before and is impacting his daily life.However, the patient reports he is very happy with his eyesight and his eyesight is good.The fluttering in his eyes happens often when exposed to bright lights like the ones in his kitchen.His eyes feel like they¿re pulsating.No specific area of the eye just all around inside the eyes, but not the eyelids.Consequently, that makes him dizzy.The symptoms are not improving with time.He is considering getting blue light blocking glasses.The patient spoke to his doctor on the phone but chooses not to go to the doctor¿s office due to covid-19.This report captures the event for the patient¿s right eye.A separate mdr is being submitted for the left eye.No further information was provided.
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
• 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: 10090551
• Report Number: 9614546-2020-00209
• Device Sequence Number: 3407004
• Product Code: POE
• UDI-Device Identifier: 05050474591752
• UDI-Public: (01)05050474591752(17)230705
• 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: 2020
• 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: 07/05/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0155
• 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: 05/06/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 05/27/2020
• 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: Other
• Date Report Sent to FDA: 01/01/2005