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	Uveitis (2122); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, an exact date was not provided but the patient's symptoms started nine (9)months post surgery of the right eye; therefore the best estimate is (b)(6) 2018.If explanted, give date: not applicable as to date the lens remains implanted and therefore not explanted.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a female patient had bilateral symfony intraocular lens (iol) implantation.(right eye: zxr00 +17.0 diopter on (b)(6) 2017 - left eye: zxr00 +18.0 diopter on (b)(6) 2018).One-month after the implantation of the iol into the left eye, the patient had inflammation after weaning off her drops.She was then started on another prednisolone wean.Since then, she has had a mild 1-2+ cell recurrent uveitis, and she was on a slow (every 2 weeks) durezol wean.She also developed uveitis in the right eye after doing a yag (yttrium aluminium garnet) capsulotomy in (b)(6) 2018 and she started slow durezol wean also in the right eye.The surgeon commented that there was nothing special about her posterior capsule opacification.It didn't appear like a chronic endophthalmitis, and the left posterior capsule was clear.She has no history of uveitis prior to phaco, and her uveitis labs and chest x-ray are normal.The patient complains of hazy vision, pain and glare.Without the durezol, she cannot open her eyes due to the photophobia.Her vision is great when the uveitis is calm.This report is to record the lens implanted in the right eye.A separate report will be filed for the left eye.No further information was provided.
Additional Manufacturer Narrative
Corrected data: the initial report 9614546-2018-00691 inadvertently did not include the verbiage to explain reason for non-evaluation: therefore, the following section has been updated accordingly: the intraocular lens (iol) is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.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
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7697603
• Report Number: 9614546-2018-00691
• Device Sequence Number: 13857762
• Product Code: POE
• UDI-Device Identifier: 05050474579033
• UDI-Public: (01)05050474579033(17)220719
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2020
• 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: 07/19/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0170
• 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: 06/25/2018
• Supplement Date Received by Manufacturer: 08/14/2018; 10/25/2020
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 09/07/2018; 10/30/2020
• 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