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	Halo (2227); No Code Available (3191)
Date of Event	12/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: unknown, information not provided.It was indicated that the device is not returning for evaluation; 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).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 a zxt150 intraocular lens (iol) was explanted from the patient's left eye on (b)(6) 2018 due to severe glare and halos.There was no patient injury and no additional intervention was required.The replacement lens model and diopter was not provided.The account commented that the explanted lens will not be returned.No additional information was provided.
Additional Manufacturer Narrative
Additional information/corrected data: additional information was received which provided new and corrected information.The implant date was (b)(6) 2018 and the explant date was (b)(6) 2018.The patient was a male with a date of birth of (b)(6) 1946.The patients symptoms were first diagnosed/reported on (b)(6) 2018.The patient is doing fine following the lens exchange.As a result, the following fields have been updated: age/date of birth: (b)(6) 1946.Gender/sex: male.Date of event: (b)(6) 2018.If implanted, give date: (b)(6) 2018.If explanted, give date: (b)(6) 2018.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 TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 8243494
• Report Number: 9614546-2019-00039
• Device Sequence Number: 14069356
• Product Code: POE
• UDI-Device Identifier: 05050474605107
• UDI-Public: (01)05050474605107(17)220615
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 06/15/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U150
• 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: 12/18/2018
• Supplement Date Received by Manufacturer: 01/16/2019; 10/25/2020
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 02/08/2019; 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
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005