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	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Date of Event	07/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, remains implanted in the eye.(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 records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.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 patient had tecnis symfony toric multifocal intraocular lens implanted on (b)(6) 2018 in patient¿s left and right eye respectively.Patient was experiencing visual issues such as starburst, hazes, rings and halos.Also having trouble judging distance at night.Additional information was received, and it was learnt that, patient noticed the visual symptoms immediately after surgery on day 1.He has only had 2 follow up appointments.The patient explained that during the day, things are fine, and he can see far, however, his near vision is not so great and cannot read from 18-20 inches from a book or computer screen.If he backs up about 30 inches away or more, he can see the computer screen/book.Therefore, he must have readers on.Patient cannot drive at night as he experiences halos around lights of on-coming traffic which makes it very difficult to see.When he looks at street lights or the moon, he sees halos, starbursts, and also sees rings/circles in the lenses.In addition, when he looks at red lights, he sees halos, starbursts, and the circles which are more extremely pronounced.He also mentioned during the night it is fuzzy, hazy, or cloudy at times.Patient indicated that he has a follow up appointment with his doctor and has brought up the issues in his last follow up appointment.His doctor stated the lens looked fine and was in the right position.This report will capture information for left eye.A separate 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 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: 8673285
• Report Number: 9614546-2019-00517
• Device Sequence Number: 2349019
• Product Code: POE
• UDI-Device Identifier: 05050474605213
• UDI-Public: (01)05050474605213(17)220614
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 06/14/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U205
• 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: 05/09/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 11/12/2020
• 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
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005