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

Model Number	ZXT225
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	09/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a tecnis symfony toric multifocal intraocular lens (model zxt225, +12.5 diopter) was explanted from the patient's operative eye in a secondary procedure because of patient experiencing visual disturbance and mild posterior capsule opacification, pco.Also reported was anisocoria - right pupil is larger in dark and light and she noticed this around early (b)(6) 2017.Another manufacturer's monofocal lens was used as the replacement lens for the patient.Reportedly patient is experiencing halos with this replacement lens.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the product was not returned to the manufacturing site as it remains implanted.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7405366
• Report Number: 9614546-2018-00330
• Device Sequence Number: 16339836
• Product Code: POE
• UDI-Device Identifier: 05050474605640
• UDI-Public: (01)05050474605640(17)211006
• Combination Product (Y/N): N
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2018

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: Physician
• Device Expiration Date: 10/06/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U125
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 06/11/2018
• 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
• Patient Age: 46 YR