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

Model Number	ZXT150
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown, not provided.If explanted, give date: not applicable, as the lens remains implanted.It was indicated that the device remains implanted and not returning for evaluation; therefore a failure analysis of the complaint device cannot be completed.A review of the device/lot 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 a zxt150 17.5 diopter lens was implanted in the patient's right eye (od) on (b)(6) 2018.Post-operatively, the lens rotated 12 degrees.The patient still has more residual cylinder than anticipated along with a myopic outcome.The patient is wearing glasses and is not happy about it.Reportedly, the patient doesn't wish to do another surgery at this time.The patient's pre-operative refraction was -2.50 x 1.50 x 168 degrees and post-operative refraction was -1.00 x 1.00 x 015 degrees, including an uncorrected visual acuity (ucva) of 20/30 and a best corrected visual acuity (bcva) of 20/20.No additional information was provided.
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
• MDR Report Key: 7736246
• Report Number: 9614546-2018-00735
• Device Sequence Number: 11017673
• Product Code: POE
• UDI-Device Identifier: 05050474605152
• UDI-Public: (01)05050474605152(17)220702
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/02/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U175
• 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: 07/02/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005