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); No Code Available (3191)
Date of Event	06/25/2019
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 zxr00 intraocular lens (iol) was explanted due to vision always fluttery causing dizziness.Follow-up confirmed that the replacement lens was an ar40e, 24.5 diopter power iol.The patient¿s visual acuity on post-op day one was 20/30.No other information was received.
Additional Manufacturer Narrative
Additional information: device available for evaluation? yes.Returned to manufacturer on: 9/12/2019.Device returned to manufacturer? yes.Device evaluation: the returned sample was received.The product was returned within the daisy wheel lens casing of its replacement along with a note indicating the identity of the lens.A visual inspection of the product with the unaided eye shows the lens was cut in half, most probably to aid in explant.Traces of ophthalmic viscosurgical device (ovd) is present on the lens surfaces.Based on the condition of the return, further analysis is not possible.The reported complaint event could not be confirmed.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order.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 (b)(4) 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: 8952792
• Report Number: 9614546-2019-00797
• Device Sequence Number: 2562312
• Product Code: MFK
• UDI-Device Identifier: 05050474579217
• UDI-Public: (01)05050474579217(17)230723
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020
• 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: 07/23/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 09/23/2019; 10/25/2020
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 10/16/2019; 11/11/2020
• 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
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005