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

Model Number	ZXT225
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Halo (2227); No Code Available (3191)
Date of Event	04/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date not provided; however it was reported as 26 weeks post-op.(b)(6) 2018 used as an approximate date.(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 was implanted with a 16.5 diopter, model zxt225 intraocular lens (iol) in her right eye (od).Approximately 26 weeks postop, the patient experienced halos, a lot of glare at night, and a lack of near visual acuity.Patient's best corrected distance visual acuity (bcdva) was 20/20.On (b)(6) 2018, original lens was exchanged with 17.0 diopter, model zct225 iol and issues have been resolved with the patient's bcdva at 20/15.No additional information provided.
Additional Manufacturer Narrative
Additional info/corrected data: additional information was received and it was learnt that the patient's visual symptoms were first reported on (b)(6) 2018.Therefore date of event was updated from (b)(6) 2018 to (b)(6) 2018.It was also reported that there was no incision enlargement, no vitrectomy was performed, no other surgical or medical intervention was required and no patient injury occurred.Reportedly, the patient is happy post-surgery.Product will not be returned as it is discarded by the surgery center.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, 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 TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7783495
• Report Number: 9614546-2018-00776
• Device Sequence Number: 1561178
• Product Code: POE
• UDI-Device Identifier: 05050474605725
• UDI-Public: (01)05050474605725(17)210714
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 11/02/2020
• 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: 07/14/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U165
• 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: 07/16/2018
• Supplement Date Received by Manufacturer: 08/15/2018; 10/25/2020
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 09/07/2018; 11/02/2020
• 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: 51 YR
• Date Report Sent to FDA: 01/01/2005