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 Code	No Code Available (3191)
Date of Event	02/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; give date: unknown, not provided.If explanted; give date: not applicable; however, a planned explanted is scheduled for (b)(6) 2019.The intraocular lens (iol) is not returning for evaluation as it remains implanted to date; 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.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient will undergo an intraocular lens (iol) replacement in (b)(6) 2019 in the left eye (os), due to intolerable glare.Visual acuity: (b)(6) 2019: os: +0.50 x -2.25 x 090 = 6/5.No further information was provided.
Additional Manufacturer Narrative
Additional information: it was reported that surgeon attempted to explant the lens in secondary surgical procedure, however was unable to explant due to the lens being too firmly fixed to the capsule and surgeon had concerns of any threatened capsular dehiscence.No further information provided.
Additional Manufacturer Narrative
Corrected data: the serial number provided in the initial mdr, 9614546-2019-00431, was incorrect.The correct serial number is (b)(4).The following have been update accordingly: brand name: tecnis symfony.Model: zxr00.Expiration date: 11/22/2022.Udi #: (b)(4).If implanted; give date: (b)(6) 2018.Manufacture date: 11/22/2017.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
New information was received.The following section has been updated accordingly: if explanted; give date: not applicable; however, a planned explant is scheduled/expected.A definitive date is pending at this time.The initially planned explant was not conducted on (b)(6) 2019 as initially reported.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-(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: 8589060
• Report Number: 9614546-2019-00431
• Device Sequence Number: 13905666
• Product Code: POE
• UDI-Device Identifier: 05050474605268
• UDI-Public: (01)05050474605268(17)220713
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,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: 11/22/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0200
• 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: 04/08/2019
• Supplement Date Received by Manufacturer: 05/09/2019; 06/19/2019; 11/27/2019; 10/25/2020
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 06/03/2019; 07/17/2019; 12/20/2019; 11/12/2020
• 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: 65 YR
• Date Report Sent to FDA: 01/01/2005