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 Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown/not provided.If explanted; give date: explant was scheduled to be on (b)(6) 2018, but not yet confirmed.(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 patient experienced symptoms of dysphotopsia post implant of a zxt225 18.5 diopter intraocular lens (iol).An explant was reported to be scheduled on (b)(6) 2018, but to date not yet confirmed.Attempts have been made to obtain further information.No additional information provided.
Additional Manufacturer Narrative
Based on new information received, iol exchange was successful and took place on (b)(6) 2018 as planned, but patient was still experiencing dysphotopsia.It was also noted that there were no secondary interventions such as incision enlargement, suture and vitrectomy required.Patient visual acuity (va) results are provided as follows: visual acuity pre-initial implant: uncorrected distance va od: 20/200, best corrected distance va od: 20/100.Visual acuity post-initial implant: uncorrected distance va od: 20/50, best corrected distance va od: 20/25.Uncorrected near va od: j3, distance-corrected near va od: j3, best corrected near va od (+1.50 add): j1.Visual acuity post-replacement: uncorrected distance va od: 20/30, best corrected distance va od: 20/25+2.Patient code 3191 - updated from planned explant to explant of intraocular lens.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 01/02/2019.Device returned to manufacturer: yes.Device evaluation: the product was received inside a plastic specimen jar inside of a re-sealable biohazard plastic bag.The product was identified as the correct product based on patient information sticker provided with the return.The product was visually inspected with the unaided eye showing the lens was cut in half, most probably to aid in explant.Based on the condition of the return, further analysis is not possible.The customer's reported complaint was not 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 other complaints have been received for this production order.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.
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.; santa ana CA 92705
• MDR Report Key: 8211057
• Report Number: 3011852734-2019-00002
• Device Sequence Number: 1670631
• Product Code: POE
• UDI-Device Identifier: 05050474605763
• UDI-Public: (01)05050474605763(17)220917
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 11/06/2020
• 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: 09/17/2022
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 01/10/2019; 02/06/2019; 10/25/2020
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 01/31/2019; 03/01/2019; 11/06/2020
• 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