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

Model Number	ZXT300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, information not provided.If explanted; give date: n/a (not applicable).Lens remains implanted.The intraocular lens (iol) 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).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zxt300 intraocular lens (iol) was implanted in the patient's right (od) operative eye on (b)(6) 2019.Patient complained that she could not see food on her plate, could not read, and could not see things in her kitchen cabinets without readers.She cannot clean her counter tops, or read a newspaper.Right eye astigmatism was not corrected.She has halos and blurry vision in both eyes, floaters in her right eye.Surgeon said because the iol was aligned with the axis there is still astigmatism.The surgeon would like to do lasik or a photorefractive keratectomy (prk) at the next follow up visit.She does not want to drive at night.When she would cover her left eye everything was blurry, when she covered her right eye everything was perfect.Left eye is working 20/20, and the surgeon told her that her right eye is 20/20 as well.She was informed that she had diabetic retinopathy about two weeks after her surgery, during second post-op visit.No further information was provided.This report represents the right eye.A separate report will be filed for the left eye.
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: 9560745
• Report Number: 9614546-2020-00012
• Device Sequence Number: 2489888
• Product Code: POE
• UDI-Device Identifier: 05050474606296
• UDI-Public: (01)05050474606296(17)220809
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020
• 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: 08/09/2022
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U155
• 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: 12/09/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 11/04/2020
• 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
• Date Report Sent to FDA: 01/01/2005