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

Model Number	ZXT225
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, as lens remains implanted.Other: the device 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 and complaint trending 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, a response has not 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 experienced severe postoperative glare at night.Original surgery (b)(6) 2019 with implant of a zxt225 toric intraocular lens (iol).The lens had rotated and was reposition (b)(6) 2019.Visual acuity pre-op: 20/200.Visual acuity post op: 20/20-1.Postoperative refraction was +0.25 +0.50 x 005 20/20.No additional information was provided.
Additional Manufacturer Narrative
Corrected data: in review of the file it was noted that additional information regarding the patient''s postoperative visual acuity was 20/20-1, j/16+ with severe glare.The comment regarding j/16+ with severe glare was inadvertently not included in section b5 of the initial report.Additional information: per follow-up, it was learned that the lens was explanted, and the reason for explant was due to the patient experiencing severe glare, no complication reported during explant, and the device was cut up and discarded.As a result of the additional information received, the following sections have been updated accordingly: section d4: explant date: (b)(6) 2019.Section h6: patient code: 3191: explant.Section h6: method code: method of 4117 that was initially provided, is now updated to 4115.All pertinent information available to johnson and 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: 8809760
• Report Number: 9614546-2019-00631
• Device Sequence Number: 10844458
• Product Code: POE
• UDI-Device Identifier: 05050474605626
• UDI-Public: (01)05050474605626(17)221118
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 11/12/2020
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2022
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U115
• 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: 06/21/2019
• Supplement Date Received by Manufacturer: 10/14/2019; 10/25/2020
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 11/04/2019; 11/13/2020
• 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