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	Visual Disturbances (2140); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, but the best estimate date is between (b)(6) 2017 and (b)(6) 2017.If explanted; give date: unknown, an exact date was not provided but the patient stated that it was (b)(6) 2018.It was indicated that the device was 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.(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
A report was received from a female patient who had a zxt150 23.5 intraocular lens (iol) implanted into her right eye (od) on (b)(6) 2017.The patient reported some issues to the surgeon about 1-2 weeks post implantation.It was noted that her distant vision was fine with 20/20, but she felt like she was looking through a "saran wrap".The patient used glasses for near vision.She was complaining of seeing spikes from light sources.There was also a ghosting issue, while reading.However, the patient could read without any issues when she used her glasses.Reportedly, the patient saw no improvement regarding her visual issues during the time the lens was implanted.Moreover, the symptoms made driving difficult.The lens was explanted and a new lens implanted (model and diopter unknown) by a second surgeon.The patient commented that the explanting surgeon would not have selected a multifocal lens initially, based on the patient's previous history with lasik surgery in od.With the replacement lens, the patient's symptoms disappeared.Additional information was received and it was learnt that the incision was not enlarged to remove the lens and there were no injuries during the explant procedure.The explanted lens was discarded by the surgeon.No additional information provided.

• 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: 7569733
• Report Number: 9614546-2018-00537
• Device Sequence Number: 1979849
• Product Code: MFK
• UDI-Device Identifier: 05050474605275
• UDI-Public: (01)05050474605275(17)210804
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 06/05/2018

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: Physician
• Device Expiration Date: 08/04/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U235
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 06/05/2018
• 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