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

Model Number	ZXT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Positive dysphotopsia, explant, incision enlargement.The intraocular lens (iol) is not returning for evaluation as it 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a symfony intraocular lens (model zxt225 +17.0 diopter) was explanted from the patient's right eye in a secondary surgical procedure, due to the patient experiencing (b)(6) dysphotopsia.Reportedly, the incision was enlarged to remove the lens.No vitrectomy was performed.A competitor lens was implanted as a replacement.The patient was reported doing well post-surgery.The product was discarded by the surgery center.No additional information was 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: 7585872
• Report Number: 9614546-2018-00563
• Device Sequence Number: 10807284
• Product Code: POE
• UDI-Device Identifier: 05050474605732
• UDI-Public: (01)05050474605732(17)211026
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2018

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: 10/26/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U170
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 06/11/2018
• 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
• Patient Age: 73 YR