MAUDE Adverse Event Report: JOHNSON AND 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); No Code Available (3191)
Date of Event	10/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zxt150, 24.5 diopter intraocular lens (iol), was explanted from a patient¿s left eye (os) due to night glare issues which interfered with driving.It was indicated that the iol was well centered and the surgery was uncomplicated.The patient had great daytime vision and was very pleased it, distance and near.However, she was unable to safely drive at night time which interfered with her work as she sometimes would need to drive at night.There was an incision enlargement in order to explant the lens.A replacement lens, zct150 with the same diopter was used.No additional information was provided.
Additional Manufacturer Narrative
Corrected data: upon further review, it was noted that the patient age was captured in the initial mdr.However, in the initial mdr it was captured as unknown/not provided.Additional information: device available for evaluation ¿ yes, returned to manufacturer on 11/16/2018 device returned to manufacturer ¿ yes.Device evaluation: visual inspection with the unaided eye shows the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.Manufacturing record review: manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specifications.Historical data analysis: a search in complaint history was performed which revealed that no similar complaint has been received for this production order number.Labeling review: the labeling review was completed and revealed that the directions for use (dfu) provide the customer with proper usage instructions and guidelines.Conclusion: 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.
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 AND JOHNSON SURGICAL VISION, INC.; 1700 east st. andrew place; santa ana CA 92705
• MDR Report Key: 8031306
• Report Number: 9614546-2018-01042
• Device Sequence Number: 11088347
• Product Code: POE
• UDI-Device Identifier: 05050474605299
• UDI-Public: (01)05050474605299(17)220615
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2020
• 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: 06/15/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 11/22/2018; 10/25/2020
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 12/20/2018; 11/04/2020
• 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