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

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); No Code Available (3191)
Date of Event	10/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; give date: unknown/not provided.The intraocular lens (iol) is not returning for evaluation as it is discarded; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, 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.(b)(4).An attempt has been made to obtain missing information; however, no definitive 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 the patient was very unhappy with her reading vision post implant of a symfony intraocular lens (iol).Pre-operative visual acuity 20/50 and post-operative visual acuity 20/25.The patient was previously a monovision patient and her reading is unacceptable.Symptoms were described as blurred vision while reading.The symfony iol was explanted from the patient's right eye and replaced with a tecnis toric iol.The explanted lens was discarded once it was bisected and removed from the eye.At explant there was no vitrectomy, incision enlargement or sutures required.At 1-day post-exchange, the patient was experiencing blurry vision 2/2 corneal edema.No other information was provided.
Additional Manufacturer Narrative
Additional: further information was provided that the patient was unhappy with near vision with the intraocular lens (iol) and wanted to go back to monovision and the surgeon was considering to explant the lens.Correction: in initial report, date received by manufacturer was incorrect.The correct date should have specified 11/14/2019.Upon further review it was noted that the serial number had 1 digit that was incorrect.Therefore, this supplemental filing is to correct the serial number and facility name and address.The implant date was updated.The following sections have been updated accordingly: serial number: (b)(4).If implanted; give date: (b)(6) 2019.(b)(6).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.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9464570
• Report Number: 9614546-2019-01104
• Device Sequence Number: 19369607
• Product Code: POE
• UDI-Device Identifier: 05050474605169
• UDI-Public: (01)05050474605169(17)230703
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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: 07/03/2023
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U180
• 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: 12/05/2019
• Supplement Date Received by Manufacturer: 12/18/2019; 10/25/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 01/13/2020; 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
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005