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

Model Number	ZXT300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Date of Event	04/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.The product was manufactured and released according to specifications.The search revealed that no similar complaints were received for this production order number.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that the patient had the iol implanted in patient¿s both operative eyes.Reportedly right eye had implant on (b)(6) 2018 and the left eye had implant on (b)(6) 2018.1 month later patient was complaining halos, starburst and night driving.Doctor has discussed possible eye drops in the future prior to night driving to help constrict pupils and has been monitoring the patient.Additional information was received, and it was learnt that at 6 months visit patient was extremely bothered starbursts and glare which is affecting night driving and daily activities.The lens in both the eyes remains implanted with no intervention planned.This report will capture information for patient¿s left eye.Another report is being submitted for patient¿s right eye.No further information 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 (b)(4) and capa-010215.
Additional Manufacturer Narrative
Additional information: additional information received indicated that the patient was seen on (b)(6) 2021 for their 1-year visit.Best corrected distance visual acuity (bcdva): 20/20 od (right eye); 20/20 os (left eye).Medical findings reported significant for dermatochalasis ou (both eyes), papilloma left upper lid.The subject reported a complaint of ocular visual symptoms as being moderately bothered by halos ¿ ¿some difficulty driving¿; moderately bothered by starbursts ¿ ¿some difficulty driving¿.In the non-directed ocular visual symptoms the subject complained of moderate halos; moderate starbursts; dryness in both eyes.All pertinent information available to johnson and johnson surgical vision 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: 8968324
• Report Number: 9614546-2019-00826
• Device Sequence Number: 18879175
• Product Code: POE
• UDI-Device Identifier: 05050474606500
• UDI-Public: (01)05050474606500(17)221027
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2021
• 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: 10/27/2022
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U260
• 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: 10/25/2020; 04/05/2021
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 11/13/2020; 05/04/2021
• 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: Other
• Patient Age: 65 YR
• Date Report Sent to FDA: 01/01/2005