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); Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2019 and (b)(6) 2019.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient implanted with a symfony toric intraocular lens (iol) complained of rings and wanted the iol explanted.Additional information received reported the iol was explanted from the right eye due to positive dysphotopsia.There were no complications at the time of surgery.However, the replacement lens was found to be rotated 90 degrees (to 180º instead of 90º).The report captures the event for the explanted iol.The report for the rotation of the replacement lens is being submitted in a separate mdr.
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 received: upon review of the folder, it was discovered that the reporter address was incorrectly reported.Additionally, the investigation results have been received.As a result, the following fields have been updated.Section e1: facility name - (b)(6) hospital (b)(6).Section e1: address line 1 - (b)(6).Section e1: city - (b)(6).Section e1: state - (b)(6).Section e1: postal code - (b)(6).Section e1: phone - (b)(6).Section d3: device evaluated by manufacturer: yes.Device evaluation: the product was not returned to the manufacturing site.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.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.H3 other text : placeholder.

• 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: 9604686
• Report Number: 9614546-2020-00028
• Device Sequence Number: 16292425
• Product Code: POE
• UDI-Device Identifier: 05050474605671
• UDI-Public: (01)05050474605671(17)220822
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• 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): 11/04/2020
• 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: 08/22/2022
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U140
• 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: 12/26/2019
• Supplement Date Received by Manufacturer: 02/04/2020; 10/25/2020
• Initial Report FDA Received Date: 01/18/2020
• Supplement Report FDA Received Date: 02/25/2020; 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